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BD SafetyGlide 305918Recalls & reported problems

Becton, Dickinson And Company · NEEDLE SFTYGLD 18X1-1/2 RB · Class 2

All models of BD SafetyGlide (17)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This BD SafetyGlide 18-gauge hypodermic needle is a shielded needle used to draw up medication and inject or withdraw fluids. The 44 reports mostly describe leakage or splashing, plastic shavings or particles on the needle or inside a syringe, a needle poking through its shield and packaging, and rubber stopper bits cored into medication. No reports describe a death or an injury. There are 44 reports in total, fewer than the 8 of the prior 12 months, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
44
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00382903059188), received between Dec 7, 2017 and Feb 20, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 reports).

4 other recalls cover devices cleared under the same FDA submission (K951254); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 2 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 3 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Leak/Splash13
  • Device Contamination with Chemical or Other Material7
  • Material Protrusion/Extrusion6
  • Component Missing4
  • Packaging Problem4
  • Contamination /Decontamination Problem3
  • Delivered as Unsterile Product2
  • Missing Information2

Patient problems

  • No Known Impact Or Consequence To Patient19
  • No Clinical Signs, Symptoms or Conditions18
  • No Consequences Or Impact To Patient4
  • Needle Stick/Puncture1
  • No Information1
  • No Patient Involvement1

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 20, 2026Contamination

    IT WAS REPORTED THAT BD NEEDLE SFTYGLD 18X1-1/2 RB CONTAINED FOREIGN MATTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I JUST RECEIVED A NOTIFICATION FROM ONE OF OUR NURSE MANAGERS AT CHESTER FACILITY. HER STAFF HAVE REPORTED TO HER THEY ARE NOTICING PARTICLES OF PLASTIC WHEN USING THIS NEEDLE. UPON NOTICING THIS, THEY HAVE NOW MOVED TO USING A DIFFERENT NEEDLE AND ARE NOT SEEING THE PARTICLES WITH THE DIFFERENT NEEDLE. WE HAVE PULLED THE NEEDLES FROM USE WITH THIS SPECIFIC LOT NUMBER UNTIL FURTHER NOTICE. WE HAVE BEEN NOTIFIED OF AN ISSUE WITH THE 18G X 1 INCH NEEDLE (MPN 305918) SPECIFIC LOT NUMBER 5321940.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24405194 ↗
  • MalfunctionNov 5, 2025Material Perforation; Material Perforation

    IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 18X1-1/2 RB NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 305918. BATCH#: 5245293. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. TODAY A NURSE BROUGHT A NEEDLE TO MY ATTENTION THAT WAS STICKING THROUGH THE PLASTIC CAP AND THE PACKAGING. SHE FELT SOMETHING SHARP, BUT NO INJURY AND IT WAS NOTICED BEFORE IT WAS USED FOR ANYTHING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23482706 ↗
  • MalfunctionOct 23, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 18X1-1/2 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305918. LOT # 5239110. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. A SCAR HAS BEEN ISSUED FOR ITEM# A3501812, BD ITEM# 305918 SAFETGLIDE HYPODERMIC NEEDLE, LOT# 5239110, FOR NONCONFORMANCE LEAKAGE FAILURE FLUID PRESSURE. ON 10/01/2025, DURING INCOMING QUALITY INSPECTION OF ITEM# A3501812 18GA X 1.5 SAFETGLIDE HYPODERMIC NEEDLE, A QUALITY INSPECTOR IDENTIFIED THAT 2 OUT OF 50 SAMPLES FAILED FOR ¿LEAKAGE FAILURE FLUID PRESSURE¿. NEEDLE SHOWED SIGNS OF CONTINUOUS DRIPPAGE. ¿LEAKAGE FAILURE FLUID PRESSURE IS A MAJOR PHYSICAL DEFECT PER INCOMING PRODUCT SPECIFICATION SPEC-MD-2000254, VERSION 13.0, SECTION 7.6.2.6, EFFECTIVE DATE 2024-10-01. THE DEFECT WAS OBSERVED IN ONE BATCH OF PRODUCT: ITEM# A3501812, BATCH 0062038824, VENDOR LOT# 5239110, QUANTITY 10.000 PIECES. PO# 4501075322 RECEIVED ON 09/29/2025. VENDOR ITEM# 305918.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23375499 ↗
  • MalfunctionSep 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 18X1-1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305918 BATCH # 5099521. REPORTING A SAFETY NEEDLE THAT LOOKS TO BE CONTAMINATED WITH WHAT APPEARS TO BE PLASTIC SHAVINGS ON THE NEEDLE. CUSTOMER RESPONSE ON (B)(6) 2025. EXACT DATE OF OCCURRENCE WAS (B)(6) 2025.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22967595 ↗
  • MalfunctionJun 24, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 18X1-1/2 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305918, BATCH#: 5008609. RCC RECEIVED A COMPLAINT VIA EMAIL. INCIDENT OR PROBLEM INFORMATION, MDIP REFERENCE NUMBER (ID): (B)(4), DATE OF INCIDENT: ON (B)(6) 2025, TYPE OF INCIDENT/PROBLEM: FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE), LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON -- INCONVENIENT, AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: USING SEFETYGLIDE NEEDLE 18G X 1/2" TO DRAW UP MAGNESIUM - MAGNESIUM DRIPPING OUT OF NEEDLE WHERE IT IS CONNECTED TO PINK BASE. IMPACT OF INCIDENT: SPILLED MAGNESIUM EVERYWHERE, RISK IF DRAWING UP CYTOTOXIC MEDICATIONS WHO WAS AFFECTED? HEALTHCARE PROFESSIONAL. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY GLIDE 18 GAUGE X 1.5 INCH, MANUFACTURER: BECTON DICKINSON CANADA INC, MANUFACTURER CODE/MODEL: 305918, SERIAL OR LOT NUMBER: (B)(6), EXPIRY DATE: 2029-12-31, SUPPLIER: (B)(6), SUPPLIER/CATALOGUE NUMBER: 308-305918, IS THE DEVICE RETAINED? YES. INVESTIGATION REQUEST: EXPECTED TYPE OF INVESTIGATION: ACTUAL DEVICE TESTED; LOT REVIEW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22324582 ↗
  • MalfunctionApr 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21878019 ↗
  • MalfunctionMar 6, 2025

    MEDICATION DRAWN UP WITH 18G X 1 1/2 IN NEEDLE. RUBBER STOPPER PIECE FOUND IN PROPOFOL SYRINGE AFTER DRAWING. MEDICATION NOT ADMINISTERED TO PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21535893 ↗
  • MalfunctionDec 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    MATERIAL#: 305918, BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. BEDSIDE RN PULLED IV LORAZEPAM FROM OMNI, PUNCTURED RUBBER STOPPER ON VIAL WITH 18G BD SAFETYGLIDE NEEDLE (REF: 305918), AND A PIECE OF RUBBER FROM THE STOPPER WAS IN THE 1ML MEDICATION SYRINGE. RN NOTICED THE PIECE OF RUBBER AND NOTIFIED DOUBLE SIGNING RN THAT DOSE SHOULD BE WASTED. BEDSIDE RN AND DOUBLE SIGNING RN WASTED DOSE IN OMNI AND DREW UP ANOTHER DOSE WITH A DIFFERENT STYLE OF NEEDLE WHICH DID NOT CAUSE ANY PIECES OF RUBBER TO ENTER THE IV LORAZEPAM OR THE MEDICATION SYRINGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20844407 ↗
  • MalfunctionDec 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20844363 ↗
  • MalfunctionDec 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    MATERIAL# 305918; BATCH# UNKNOWN. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. BEDSIDE RN PULLED IV LORAZEPAM FROM OMNI, PUNCTURED RUBBER STOPPER ON VIAL WITH 18G BD SAFETYGLIDE NEEDLE (REF: 305918), AND A PIECE OF RUBBER FROM THE STOPPER WAS IN THE 1ML MEDICATION SYRINGE. RN NOTICED THE PIECE OF RUBBER AND NOTIFIED DOUBLE SIGNING RN THAT DOSE SHOULD BE WASTED. BEDSIDE RN AND DOUBLE SIGNING RN WASTED DOSE IN OMNI AND DREW UP ANOTHER DOSE WITH A DIFFERENT STYLE OF NEEDLE WHICH DID NOT CAUSE ANY PIECES OF RUBBER TO ENTER THE IV LORAZEPAM OR THE MEDICATION SYRINGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20844231 ↗
  • MalfunctionFeb 7, 2024Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLES LEAKED AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSES REPORTED THAT NEEDLES WERE LEAKING FROM THE LOCATION WHERE THE NEEDLE MEETS THE PINK PLASTIC." PRODUCT#: 305918. LOT#: 3206801.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18664884 ↗
  • MalfunctionJan 18, 2024

    NURSES REPORTED THAT NEEDLES WERE LEAKING FROM THE LOCATION WHERE THE NEEDLE MEETS THE PINK PLASTIC.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18535231 ↗
  • MalfunctionJan 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE BD SAFETYGLIDE HAD RUST/CORROSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD SAFETYGLIDE NEEDLE 18GX1.5" HAD RUST ON SHAFT OF NEEDLE. LOT # 3114521 EXP: 03/31/2028." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. EVENT DATE: (B)(6) 2023. EVENT LOCATION: (B)(6). EVENT DESCRIPTION: BD SAFETYGLIDE NEEDLE 18GX1.5" HAD RUST ON SHAFT OF NEEDLE. LOT # 3114521 EXP: 03/31/2028. HARM TO TEAM MEMBER OR PATIENT? NO. PRODUCT NAME: NEEDLE SAFETY 18G X 1 1/2". PRODUCT REF: 305918. LOT NUMBER: 3114521. BD CUSTOMER ACCOUNT NUMBER: (B)(6). FURTHER INFORMATION PROVIDED BY REPORTER: 1. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? NO IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 2. WHAT WAS THE PATIENT OUTCOME? NOT ABLE TO PROVIDE. 3. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? SLIGHT DELAY. 4. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? THE NEEDLE WAS NOT USED ON THE PATIENT; NO INJURY. 5. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? INDIRECTLY; NEEDLE WAS INTENDED FOR PATIENT USE BUT WAS NOT USED ON PAT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18461476 ↗
  • MalfunctionFeb 23, 2023Leak/Splash; Leak/Splash

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 18 G X 1 1/2 IN. LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING AT FUSED CONNECTION WHILE MIXING MEDICATION. NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16427788 ↗
  • MalfunctionNov 9, 2022Missing Information; Missing Information

    IT WAS REPORTED THAT THE LABELS OF 1000 BD SAFETYGLIDE¿ NEEDLES HAD THEIR EXPIRATION DATE CUT OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR QC TEAM HAS IDENTIFIED EXPIRATION DATES CUT OFF OF QTY 1,000 OF P/N 305918"

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15762512 ↗
  • MalfunctionOct 12, 2022Missing Information; Missing Information

    IT WAS REPORTED THAT 25 BD SAFETYGLIDE¿ NEEDLES WERE MISSING SOME OF THE PRINTED INFORMATION ON THEIR LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TEAMMATES DISCOVERED 5 EACH NEEDLES WITHOUT PACKAGING PRINT IN THE BOTTOM LAYER OF 5 SEPARATE BOXES LOT 2136978. 5 NEEDLES WITHOUT PRINT WERE FOUND IN THE BOTTOM LAYER OF 5 BD NEEDLE BOXES. THE QA TEAM ACCEPTED THE REMAINING RAW MATERIAL OF LOT 2136978, NO ADDITIONAL NEEDLES MISSING PRINT WERE DISCOVERED, THERE IS NO MATERIAL ON HOLD."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15588081 ↗
  • MalfunctionSep 22, 2022Defective Component; Defective Component

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A NEEDLE BREAK AT THE BASE THEN NOT ALLOWING US TO ENGAGE THE SAFETY GLIDE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15464900 ↗
  • MalfunctionAug 19, 2021Packaging Problem; Packaging Problem

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE PIERCED THROUGH THE BOTTOM WEB OF THE PACKAGING DUE TO HAVING NO SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISSING SAFETY CAP ON NEEDLE." VIA BD INVESTIGATION: "THE SAMPLE WAS VISUALLY EVALUATED. IT WAS IMMEDIATELY OBSERVED THROUGH THE PACKAGE THAT THE NEEDLE WAS UNSHIELDED AND HAD PENETRATED THE BOTTOM WEB. UPON OPENING THE PACKAGE AND EXAMINING THE NEEDLE, SCUFF MARKS COULD BE SEEN UNDERNEATH THE NEEDLE HUB WHERE THIS NEEDLE WOULD HAVE TRAVELED THROUGH THE PACKAGER WITHOUT ITS SHIELD."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12344594 ↗
  • MalfunctionJan 5, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD SAFETYGLIDE¿ NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF OUR NURSES REPORTED A BROKEN NEEDLE."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11115068 ↗
  • MalfunctionAug 25, 2020Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

    IT WAS REPORTED THAT NEEDLE SFTYGLD 18X1-1/2 RB BROKE. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN NEEDLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10446743 ↗
  • MalfunctionAug 5, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

    IT WAS REPORTED THAT DURING USE WITH A BD SAFETYGLIDE¿ NEEDLE WHEN ATTEMPTING TO ENGAGE THE SAFETY MECHANISM THE NEEDLE CAME OUT OF SAFETY SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NURSE WAS DRAWING UP MEDICATION OUT OF A BOTTLE AND WHEN SHE ATTEMPTED SLIDE THE SAFETY MECHANISM THE NEEDLE POPPED OUT OF THE SAFETY SHIELD.

    Patient problems: No Patient Involvement

    MAUDE report 10368963 ↗
  • MalfunctionJul 29, 2020Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE SFTYGLD 18X1-1/2 RB EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (YYYY-MM-DD): 2020 (B)(6). TYPE OF INCIDENT/PROBLEM: MALFUNCTION - DURING OR AFTER USE. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE. INCIDENT DETAILS: SOLUTION WAS DRAWN UP INTO A SYRINGE, A NEEDLE WAS ATTACHED AND WHEN THE SOLUTION WAS BEING INJECTED INTO AN IV BAG THE AREA AROUND THE HUB OF THE NEEDLE WAS LEAKING. THE NEEDLE WAS ATTACHED CORRECTLY AND THIS PROBLEM HAPPENED ON MORE THAN ONE OCCASION. WHO WAS AFFECTED? NO PERSON AFFECTED. UNEXPECTED OR PROLONGED CARE? NO. FREQUENCY OF PROBLEM: RECURRING. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY GLIDE 18 GAUGE X 1.5 INCH. MANUFACTURER CODE/MODEL: 305918. SERIAL OR LOT NUMBER: 9170953.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10339905 ↗
  • MalfunctionJul 7, 2020Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

    IT WAS REPORTED THAT THE NURSE SUSTAINED A NEEDLE STICK WITH A CLEAN, STILL-PACKAGED BD SAFETYGLIDE¿ NEEDLE THAT HAD NO CAP ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF MEMBER SUFFERED A NEEDLESTICK INJURY. SHE WAS REACHING INTO A BIN IN THE MEDICATION ROOM AND WAS STUCK BY THE NEEDLE WHICH WAS STILL IN THE SEALED PACKAGE AND HAD NO CAP ON IT. SHE WAS NOT HARMED, AND THEY DID NOT RETAIN THE NEEDLE."

    Patient problems: Needle Stick/Puncture

    MAUDE report 10243052 ↗
  • MalfunctionMay 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

    IT WAS REPORTED THAT SAFETY CAP WAS MISSING AND NEEDLE WAS STICKING OUT OF PACKAGING THUS AFFECTING STERILITY WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS NO SAFETY CAP ON NEEDLE AND NEEDLE WAS POKING OUT OF THE PACKAGE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10031271 ↗
  • MalfunctionJan 29, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

    IT WAS REPORTED THAT SAFETY COVER BROKE AT HINGE WHEN SAFETY ACTIVATED WITH A BD SAFETYGLIDE¿ NEEDLE. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PLASTIC HINGED COVER BROKE AT THE HINGE WHEN THE SAFETY WAS ACTIVATED. ADDITIONALLY, ON 2020-01-10 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WHICH FACILITY DID IT OCCUR AT? (B)(4). LOT NUMBER OR SERIAL NUMBER IF AVAILABLE ¿ LOT # 9323614. DID IT ONLY OCCUR ONCE? NURSE WHO REPORTED THIS EVENT SAID IT HAPPENED ONCE BEFORE. DID IT RESULT IN ANY NEEDLESTICK INJURY? NO. DO YOU HAVE THE SAMPLE TO SEND IN FOR INVESTIGATION? NO. THE NURSE STATED IT HAPPENED ONCE BEFORE ¿ DID SHE PROVIDE YOU WITH A DATE OF OCCURRENCE FOR THE OTHER TIME IT HAPPENED OR WAS THAT DATE UNKNOWN? ANSWER: UNFORTUNATELY THE NURSE DIDN¿T STATE THE DATE OF OCCURRENCE SO I BELIEVE IT WAS UNKNOWN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9643089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951254. One submission often covers many models, so check the product and lot details in each record.

  • Z-2889-2020 · Jul 28, 2020 · Terminated
    BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
  • Z-0315-2018 · Jul 5, 2017 · Terminated
    SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
  • Z-3116-2017 · Jun 13, 2017 · Terminated
    BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from
  • Z-2748-2017 · Sep 16, 2016 · Terminated
    BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below th

Other Needle, hypodermic, single lumen devices

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Sources and updates

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