Skip to content

N/A 305127Recalls & reported problems

Becton, Dickinson And Company · NEEDLE 25X1-1/2 RB · Class 2

Quick summary

This BD Precision Glide hypodermic needle is a single-use needle used for injections. Its 82 reports mostly describe needles that clogged, broke, leaked, or had residue or foreign matter on the shaft; there are no deaths and 11 injuries, including a needle that broke during surgery and was removed from a patient's lung. No recalls name this device. Reports dropped from 12 to 4 over the last 12 months.

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
82
Deaths reported
0
Injuries reported
11
Recalls naming it
0

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00382903051274), received between Dec 20, 2017 and May 5, 2026 — classified as 11 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (28 reports).

3 other recalls cover devices cleared under the same FDA submission (K021475); 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 2 reportsDec 2023: 2 reportsJan 2024: 3 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 2 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 4 reportsFeb 2025: 3 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Complete Blockage28
  • Break14
  • Leak/Splash9
  • Detachment of Device or Device Component4
  • Device Contamination with Chemical or Other Material4
  • Contamination3
  • Contamination /Decontamination Problem3
  • Material Puncture/Hole3

Patient problems

  • No Clinical Signs, Symptoms or Conditions41
  • No Known Impact Or Consequence To Patient13
  • Foreign Body In Patient7
  • No Consequences Or Impact To Patient7
  • Insufficient Information3
  • Needle Stick/Puncture3
  • Discomfort2
  • Inadequate Pain Relief2

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 5, 2026Contamination

    IT WAS REPORTED, NEEDLE WITH THE WHITE RESIDUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25086657 ↗
  • MalfunctionApr 8, 2026Contamination

    IT WAS REPORTED BY CUSTOMER THAT WITHDREW THE NEEDLE AND NOTED A WHITE CERAMIC APPEARING SUBSTANCE ALONG THE SHAFT, SIMILAR TO THE FORMED HARDENED SUBSTANCE AT THE BASE OF THE NEEDLE THAT ADJOINS THE NEEDLE SHAFT TO THE BLUE BASE HUB OF THE NEEDLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24816055 ↗
  • MalfunctionDec 30, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT BD NEEDLE 25X1-1/2 RB CAUSED LEAKAGE. VERBATIM: DURING INJECTION OF PATIENTS WRIST, NEEDLE LEAKED A COUPLE DROPS OF SOLUTION. DR WAS ABLE TO FINISH PATIENTS INJECTION. NEEDLE WAS REMOVED AND INCIDENT REPORTED. OTHER NEEDLES FROM LOT WERE TESTED WITH NO ISSUES NOTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23927656 ↗
  • MalfunctionDec 23, 2025Contamination; Contamination

    IT WAS REPORTED THAT BD PRECISION GLIDE NEEDLE CONTAINED FOREIGN MATTER. MATERIAL #305127; LOT #2175239. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I AM REACHING OUT FROM A PHYSICIAN'S OFFICE. ONE OF OUR PROVIDER'S WAS GOING TO USE ONE OF YOUR NEEDLES, UNFORTUNATELY, IT WAS FAULTY. THE NEEDLE HAD A PIECE OF METAL STUCK IN IT, AND THE PHYSICIAN WASN'T ABLE TO USE IT. WAS ADVISED TO REACH OUT TO THE MANUFACTURER TO FOLLOW-UP. THERE WAS NO SERIOUS INJURY OR EVENT, JUST ISSUE WITH THE PRODUCT. NAME: BD PRECISION GLIDE NEEDLE. SIZE: 25G X 1 1/2 (0.5MM X 40MM). REF: (B)(4). LOT: 2175239. EXPIRY: 2027-08-31. (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23884041 ↗
  • MalfunctionJun 6, 2025Break; Break

    MATERIAL: 305127 BATCH#: 4247061. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE BROKE AT HUB WHILE INJECTING PATIENT DURING ROBOTIC SURGERY. RCC RECEIVED A COMPLAINT VIA EMAIL. 25-GAUGE NEEDLE BROKE AT HUB WHILE INJECTING PATIENT DURING ROBOTIC SURGERY. THE NEEDLE MIGRATED TO THE PATIENT'S LUNG AND WAS REMOVED VIA ROBOTIC EXPLORATORY SURGERY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ROBOTIC THYMECTOMY WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE; NOT KNOWN.

    Patient problems: Foreign Body In Patient

    MAUDE report 22157604 ↗
  • InjuryMay 21, 2025Break; Material Fragmentation; Migration

    25-GAUGE NEEDLE BROKE AT HUB WHILE INJECTING PATIENT DURING ROBOTIC SURGERY. THE NEEDLE MIGRATED TO THE PATIENT'S LUNG AND WAS REMOVED VIA ROBOTIC EXPLORATORY SURGERY.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 22060196 ↗
  • MalfunctionMay 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    MATERIAL: 305127 BATCH: 4262992 IT WAS REPORTED BY THE CUSTOMER THAT NOTICED A WHITE RESIDUE DIRECTLY ON THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM CONTACTING YOU TO REPORT AN ISOLATED QUALITY CONCERN REGARDING A BD PRECISIONGLIDE 25G X 1½ TW NEEDLE (REF 305127), LOT NUMBER 4262992, WITH AN EXPIRY DATE OF 20290831. A PATIENT CAME TO MY PHARMACY AFTER USING THIS NEEDLE, WHICH HAD BEEN DISPENSED BY ANOTHER PHARMACY. THE PRIMARY PACKAGING WAS INTACT PRIOR TO USE. DURING THE INJECTION, THE PATIENT EXPERIENCED ABNORMAL RESISTANCE, AND AFTERWARD NOTICED A WHITE RESIDUE DIRECTLY ON THE NEEDLE. THE NEEDLE WAS USED BEFORE THE ISSUE WAS IDENTIFIED. NO ADVERSE EFFECTS HAVE BEEN REPORTED, AND THE PATIENT WAS REASSURED. A PHOTO IS ATTACHED TO THIS EMAIL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22053998 ↗
  • MalfunctionFeb 21, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED.

    Patient problems: Insufficient Information

    MAUDE report 21433536 ↗
  • MalfunctionFeb 18, 2025Defective Component; Defective Component

    MATERIAL #305127. LOT #4159462. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. STARTING IN DECEMBER 2024, WE HAVE SEEN A SUDDEN UPTICK IN THE NUMBER OF VIALS THAT ARE CORING AFTER BEING ACCESSED USING THE PRECISIONGLIDE BLUNT FILL NEEDLE. THIS HAS BEEN ACROSS MULTIPLE USERS AND LOCATIONS, AND PROPER TECHNIQUE HAS BEEN VERIFIED.

    Patient problems: Insufficient Information

    MAUDE report 21394583 ↗
  • MalfunctionFeb 13, 2025Complete Blockage; Complete Blockage

    MATERIAL # 305127. BATCH # UNKNOWN. VERBATIM: THE NEEDLE IS GETTING STUCK SO THE FULL AMOUNT OF MEDICATION CANNOT BE INJECTED. THIS (B)(4) HAS BEEN CREATED FOR THE 6TH OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21375259 ↗
  • InjuryJan 31, 2025Break; Break

    MATERIAL # 305127 BATCH # 4081101 VERBATIM: THE CUSTOMER ADVISED THAT THE PRECISION NEEDLE BROKE DURING AN OPERATION. 1. WHAT WAS THE IMPACT TO THE PATIENT? SLIGHT DISCOMFORT AND SLIGHT VARIATION IN SCHEDULE TO GET ORDERED XRAY PERFORMED. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. PATIENT HAD SLIGHT DISCOMFORT BUT REPORTED NO PAIN. THE NEEDLE HAS NOW SURFACED AS OF (B)(6) 2025 AND THE PATIENT WAS ABLE TO PULL THE NEEDLE OUT.

    Patient problems: Discomfort; Foreign Body In Patient

    MAUDE report 21283976 ↗
  • MalfunctionJan 31, 2025Complete Blockage; Complete Blockage

    MATERIAL # 305127. BATCH # 3209587, 4081101. VERBATIM: THE NEEDLE IS GETTING STUCK SO THE FULL AMOUNT OF MEDICATION CANNOT BE INJECTED OCCURRENCES: 5 EA (BETWEEN TWO BOXES).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21283256 ↗
  • MalfunctionJan 20, 2025Complete Blockage; Complete Blockage

    NO ADDITIONAL INFORMATION RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21191342 ↗
  • InjuryJan 11, 2025Material Separation; Material Separation

    MATERIAL#: 305127, BATCH#: UNKNOWN (PROVIDED LOT#: 381232). RCC RECEIVED A COMPLAINT VIA EMAIL. THE NEEDLE BROKE OFF THE HUB AND WAS LODGED IN THE PATIENT DURING USE. INTERVENTIONAL RADIOLOGY TRIED TO RETRIEVE THE NEEDLE AND WAS UNSUCCESSFUL. SURGERY WAS CONSULTED. THE DECISION WAS MADE NOT TO SURGICALLY REMOVE THE NEEDLE. 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. UNKNOWN, THE NEEDLE BROKE OFF THE HUB AND WAS LODGED IN THE PATIENT DURING USE. 2. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? GIVEN LOT#: 381232 NOT VALID.25G 1 1/2 INCH PRECISION GLIDE NEEDLE THIS IS A NEEDLE THAT WE USE TO DELIVER LIDOCAINE TO A PATIENT DURING A PROCEDURE. IT COMES IN OUR PRE-MADE STERILE ANGIOPLASTY PACKS. THE CURRENT LOT# FOR THESE PACKS IS 381232. CATALOG: SAN30AGSBD FROM CARDINAL HEALTH. 3. TOTAL NUMBER OF OCCURRENCES? UNKNOWN. 4. 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?

    Patient problems: Foreign Body In Patient

    MAUDE report 21133535 ↗
  • MalfunctionDec 14, 2024Material Puncture/Hole; Material Puncture/Hole

    MATERIAL # 305127 BATCH # 3083311. CUSTOMER SAID WHEN PUSHING MEDICATION, IT SHOOTS OUT THE HOLE INSTEAD OF THE NEEDLE. NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20932785 ↗
  • MalfunctionDec 4, 2024Leak/Splash; Leak/Splash

    MATERIAL#: 305127. BATCH NUMBER#: UNKNOWN. VERBATIM#: PLEASE FIND ATTACHED THE NEEDLE EXTENDER VIDEO OF THE LEAK THAT I EITHER MENTIONED TO YOU OR ROB A MONTH OR 2 AGO. I HAVE ALSO ATTACHED THE NEEDLES THAT THEY ARE USING. IF YOU COULD KINDLY HELP US TROUBLE SHOOT AS IT HAS BEEN LEAKING FOR ALMOST LAST 1 YEAR AND WE JUST BOUGHT IT LAST YEAR

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20844603 ↗
  • InjuryOct 24, 2024Break; Break

    MATERIAL # 305127, BATCH # 3299707. IT WAS REPORTED BY CUSTOMER THAT PRECISION GLIDE NEEDLE BROKE OFF IN PT AT THE HUB, X-RAY AND SCHEDULED SURGERY FOR REMOVAL.

    Patient problems: Foreign Body In Patient

    MAUDE report 20522150 ↗
  • MalfunctionSep 6, 2024Break; Break

    MATERIAL: 305127. BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE MAY BREAK OFF IN THE PATIENT'S BREAST. ADDITIONAL INFORMATION FROM CUSTOMER: YES, THE NEEDLE BROKE OFF BUT I WAS ABLE TO RETRIEVE IT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20155716 ↗
  • MalfunctionAug 22, 2024Break; Break

    MATERIAL#: 305127. BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE BROKE OFF DURING A PROCEDURE AND THE SURGEON WAS ABLE TO RETRIEVE IT WITH NO HARM TO THE PATIENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED MEDICATION NEEDLE HYPODERMIC 25 GAGE, 1.5-INCH BLUE ¿ MFG# 305127 NEEDLE BROKE OFF DURING A PROCEDURE AND THE SURGEON WAS ABLE TO RETRIEVE IT WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION: 1. KINDLY PROVIDE THE BATCH/LOT NUMBER OF THE PRODUCT. ¿ PRODUCT LOT WAS NOT DOCUMENTED 2. CAN YOU SHARE ANY PHYSICAL SAMPLE IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? ¿ PRODUCT WAS DISPOSED. 3. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? NO PICTURES WERE TAKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20032098 ↗
  • MalfunctionAug 20, 2024Complete Blockage; Complete Blockage

    ADDITIONAL INFORMATION RECEIVED: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO SERIOUS EVENTS BUT WHEN THERE IS A CLOGGED NEEDLE, I HAVE TO INJECT PATIENT MULTIPLE TIMES OR EVEN WASTE PRODUCT, IT IS A SIGNIFICANT INCONVENIENCE MATERIAL: UNKNOWN BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE DEFECTIVE NEEDLES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAVE DEFECTIVE NEEDLES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20003208 ↗
  • MalfunctionJul 26, 2024Material Separation; Material Separation

    MATERIAL# 305127, BATCH# 3320216 #3320217. IT WAS REPORTED BY CUSTOMER THAT NEEDLES BREAK APART FROM THE BLUE HUB WHILE PULLING CAP OFF. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: JULY 11, 2024. * NAME: XXXXXXX. * PHONE/EXTENSION: XXXXXXX. * DEPARTMENT/SERVICE: PAIN MANAGEMENT PROGRAM / MEDICINE SERVICES. * COST CENTRE: (B)(4). VENDOR NAME: BD PRECISONGLIDE NEEDLE 25G X 1 ½ ¿ TW (0.5MM X 40MM). HMMS ITEM ID: 3194. MANUFACTURER CATALOGUE NUMBER: 305127. VENDOR CATALOGUE NUMBER: BD305127. DESCRIPTION OF ITEM: INCLUDE LOT NUMBER IF AVAILABLE 3320216. COMMENTS: WE HAVE HAD 2 NEEDLES BREAK APART FROM THE BLUE HUB WHILE PULLING CAP OFF ¿ THERE IS CONCERN OF PATIENT SAFETY - AS A PHYSICIAN IS AWARE OF A SITUATION AT LHSC WHERE A PATIENT HAS A NEEDLE LODGED IN THEIR BACK. WE HAVE REMOVED THESE NEEDLES WITH LOT 3320216 AND 3320217 FROM OUR EXAM ROOMS BUT WILL NEED REPLACEMENTS ASAP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19837475 ↗
  • MalfunctionMay 13, 2024Complete Blockage; Complete Blockage

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305127, BATCH#: 3299707. IT WAS REPORTED BY THE CUSTOMER THAT I HAVE HAD SO MANY OF THESE NEEDLES LATELY WHERE THE CAP WON¿T COME OFF AND SOME THAT ARE CLOGGED SO I WON¿T GET A FLASH. IS THIS SOMETHING THAT OTHERS HAVE COMPLAINED ABOUT? I FIND MYSELF TOSSING SO MANY OF THESE. LET ME KNOW YOUR THOUGHTS. VERBATIM: I HAVE HAD SO MANY OF THESE NEEDLES LATELY WHERE THE CAP WON¿T COME OFF AND SOME THAT ARE CLOGGED SO I WON¿T GET A FLASH. IS THIS SOMETHING THAT OTHERS HAVE COMPLAINED ABOUT? I FIND MYSELF TOSSING SO MANY OF THESE. LET ME KNOW YOUR THOUGHTS. COMMENTS 08/05/2024. I HAVE THE NEEDLES AND WOULD BE GLAD TO SHIP THEM TO YOU - WILL YOU SEND ME A PACKAGE? I STARTED SAVING THE NEEDS THAT THE CAP DOES NOT COME OFF OF - I DO NOT SAVE THE NEEDS THAT DON'T FLASH BECAUSE THEY ARE USED. HOW WOULD YOU LIKE ME TO SEND THEM TO YOU? 1. DATE OF EVENT: THIS OCCURS REGULARLY - SEVERAL TIMES A WEEK. 2. NOT LIFE THREATENING, JUST INCONVENIENT THAT I CANNOT USE NEEDLE OR THAT I INJECT NEEDLE AND THE HUB IS BLOCKED SO DOES NOT RETURN A FLASH. 3. NO PATIENT HARM - JUST ADDITIONAL INJECTIONS BUT NEEDLE IS BLOCKED SO DOES NOT RETURN A FLASH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19296738 ↗
  • MalfunctionMar 28, 2024

    DURING A SURGICAL CASE, THE PERIOPERATIVE NURSE WAS STUCK WITH A BD 25GX1.5 NEEDLE DUE TO A MALFUNCTION OF THE NEEDLE. A PICTURE IS ATTACHED OF THE NEEDLE. REFERENCE REPORT #MW5153344.

    Patient problems: Needle Stick/Puncture

    MAUDE report 19002612 ↗
  • MalfunctionJan 29, 2024Material Fragmentation; Material Fragmentation

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305127 BATCH#: 3083311. IT WAS REPORTED BY CUSTOMER THAT DEFECTIVE NEEDLE CONCERN VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BD PRECISIONGLIDE NEEDLE 25G X 11/2" TW (0.5MM X 40MM). REF 305127. BECKTON, DICKINSON AND COMPANY. LOT 3083311. DEFECTIVE NEEDLE CONCERN. ADDITIONAL INFORMATION FROM EMAIL CHAIN: BD PRECISIONGLIDE NEEDLE. 25G X 11/2" TW (0.5MM X 40MM). REF 305127. BECKTON, DICKINSON AND COMPANY. LOT 3083311. GOOD MORNING, I WAS ASSISTING DR. (B)(6) IN CLINIC THIS AFTERNOON (B)(6) 2024. HE WAS PERFORMING AN US GUIDED INJECTION INTO A PATIENT'S FOOT. WE NOTICED THAT THE NEEDLE HE HAD INSERTED INTO THE PATIENT WAS LEAKING MEDICATION AROUND THE HUB INSTEAD OF THROUGH THE END OF THE NEEDLE TIP. HE WITHDREW THE NEEDLE AND TIGHTENED THE NEEDLE ONTO THE SYRINGE MAKING SURE IT WAS FIRM. HE INSERTED THE NEEDLE AGAIN AND PUSHED THE PLUNGER TO INSERT THE MEDICATION. WE THEN NOTICED THAT THE LIQUID WAS COMING OUT FROM A SMALL HOLE ON THE SIDE OF THE HUB. THE MEDICATION FROM THE SMALL HOLE MADE AN AUDIBLE HISSING SOUND. HE WITHDREW THE NEEDLE AND I ASSISTED OPENING A NEW NEEDLE A

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18594866 ↗
  • MalfunctionJan 29, 2024Material Puncture/Hole; Material Puncture/Hole

    NO ADDITIONAL INFORMATION RECEIVED  MATERIAL #: 305127 BATCH#: 3083311 IT WAS REPORTED BY CUSTOMER THAT DEFECTIVE NEEDLE CONCERN VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BD PRECISIONGLIDE NEEDLE 25G X 11/2" TW (0.5MM X 40MM) REF (B)(4) BECKTON, DICKINSON AND COMPANY LOT 3083311 DEFECTIVE NEEDLE CONCERN ADDITIONAL INFORMATION FROM EMAIL CHAIN: BD PRECISIONGLIDE NEEDLE 25G X 11/2" TW (0.5MM X 40MM) REF (B)(4) BECKTON, DICKINSON AND COMPANY LOT 3083311 GOOD MORNING, I WAS ASSISTING DR. (B)(6) IN CLINIC THIS AFTERNOON (B)(6) 2024. HE WAS PERFORMING AN US GUIDED INJECTION INTO A PATIENT'S FOOT. WE NOTICED THAT THE NEEDLE HE HAD INSERTED INTO THE PATIENT WAS LEAKING MEDICATION AROUND THE HUB INSTEAD OF THROUGH THE END OF THE NEEDLE TIP. HE WITHDREW THE NEEDLE AND TIGHTENED THE NEEDLE ONTO THE SYRINGE MAKING SURE IT WAS FIRM. HE INSERTED THE NEEDLE AGAIN AND PUSHED THE PLUNGER TO INSERT THE MEDICATION. WE THEN NOTICED THAT THE LIQUID WAS COMING OUT FROM A SMALL HOLE ON THE SIDE OF THE HUB. THE MEDICATION FROM THE SMALL HOLE MADE AN AUDIBLE HISSING SOUND. HE WITHDREW THE NEEDLE AND I ASSISTED OPENING A NEW NEEDLE AND PLACED

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18594864 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.

  • Z-0588-2021 · Nov 18, 2020 · Terminated
    BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
  • Z-0207-2018 · May 31, 2017 · Terminated
    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
  • Z-1009-2012 · Oct 8, 2011 · Terminated
    BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications

Other Needle, hypodermic, single lumen devices

All Needle, hypodermic, single lumen devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.