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N/A 305196Recalls & reported problems

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

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This BD hypodermic needle is a single-use needle used for injections. The 88 reports mostly describe white residue or excess glue on the needles, needles separating from their base, and other foreign matter, often caught before use. There were no deaths and two injuries reported. 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
88
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00382903051960), received between Dec 18, 2017 and Mar 18, 2026 — classified as 2 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (32 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: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 2 reportsMar 2024: 3 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 2 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 3 reportsJan 2025: 0 reportsFeb 2025: 4 reportsMar 2025: 2 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 3 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 3 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 2 reportsApr 2026: 0 reportsMay 2026: 0 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

  • Device Contamination with Chemical or Other Material32
  • Defective Component11
  • Contamination10
  • Leak/Splash7
  • Contamination /Decontamination Problem5
  • Device Markings/Labelling Problem3
  • Complete Blockage2
  • Contamination of Device Ingredient or Reagent2

Patient problems

  • No Clinical Signs, Symptoms or Conditions58
  • No Known Impact Or Consequence To Patient17
  • Insufficient Information5
  • No Patient Involvement4
  • No Consequences Or Impact To Patient2
  • Foreign Body In Patient1
  • Fungal Infection1

Recent adverse event reports

The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 18, 2026Contamination

    IT WAS REPORTED BY THE CUSTOMER THAT FOUND 18G NEEDLES WITH WHITE RESIDUE AT THE BASE. NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24626688 ↗
  • MalfunctionMar 8, 2026Contamination

    WHITE BUILD UP ON SEALED NEEDLES, APPEAR TO BE EXCESS GLUE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24542069 ↗
  • MalfunctionFeb 27, 2026Material Separation

    IT IS REPORTED NEEDLE SEPARATED FROM HUB. DESCRIPTION: IT APPEARS AS THOUGH THE COLOURED NEEDLE BASE DISCONNECTED FROM THE NEEDLES, AND THE NEEDLES THEMSELVES REMAINED INSIDE THE CAP CASE. NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24470808 ↗
  • MalfunctionFeb 11, 2026Material Deformation

    IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE IS WARPED. IT WILL NOT LUER-LOCK INTO SYRINGE. DURING USE. NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24313187 ↗
  • MalfunctionDec 31, 2025Contamination; Contamination

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:305196, BATCH#:5029970. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DATE: 08.12.2025. CLAIM NUMBER: (B)(4). ACCOUNT NUMBER: (B)(4). ARTICLE NUMBER: 308-305196. LOT # / SERIAL #: (B)(6). SAMPLE AVAILABLE: CONFIRMING. PICTURES: REQUESTING. PRODUCT DESCRIPTION: NDL BD GENERAL REG BVL 18GX1.5" STER. DESCRIPTION OF INCIDENT: AS PER ACCOUNT, CLINICIANS OBSERVED THE PRESENCE OF A WHITE MATTER ON SOME NEEDLES. NO PATIENTS WERE AFFECTED. THE BOXES FROM THIS BATCH WERE REMOVED FROM USE AND SET ASIDE BY THE ICU TEAM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23936954 ↗
  • MalfunctionDec 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 RB HAD EXCESSIVE EPOXY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305196BATCH#: 5029970. 1. SEND A TRANSPORT TUBE FOR SHIPPING A SAMPLE TO THE FOLLOWING ADDRESS: A WHITE SUBSTANCE IS FOUND ON SOME OF THE NEEDLES: OUR CLINICIANS OBSERVED THE PRESENCE OF A WHITE SUBSTANCE ON SOME OF THE NEEDLES (PHOTOS ATTACHED). NO PATIENTS WERE AFFECTED. THE BOXES FROM THIS BATCH HAVE BEEN REMOVED FROM USE AND SET ASIDE BY THE INTENSIVE CARE TEAM. SEND A TRANSPORT TUBE FOR SHIPPING THE SAMPLE TO THE FOLLOWING ADDRESS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23799571 ↗
  • MalfunctionNov 27, 2025Material Integrity Problem; Material Integrity Problem

    POST INVESTIGATION RESULTS INDICATE AN ADDITIONAL FAILURE OF EPOXY DRIP-OVER ON THE NEEDLE HUB.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23665602 ↗
  • MalfunctionNov 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305196, BATCH#: 5029974. RCC RECEIVED A COMPLAINT VIA EMAIL. THERE IS A BLACK MARK ON BD 18G NEEDLE OUR TEAM MEMBER NOTICED UPON OPENING. NEEDLE WAS NOT USED. INCIDENT DATE: ON (B)(6) 2025. 305196, 5029974.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23501126 ↗
  • MalfunctionNov 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305196. BATCH # 4305258. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THERE IS A BLACK MARK ON BD 18G NEEDLE OUR TEAM MEMBER NOTICED UPON OPENING. NEEDLE WAS NOT USED. ATTACHED PICTURE HAS LOT AND EXPIRATION DATE. INCIDENT DATE: (B)(6) 2025. NEEDLE IS AVAILABLE TO BE RETURNED FOR FURTHER INVESTIGATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23493261 ↗
  • MalfunctionAug 25, 2025Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

    IT IS REPORTED FOREIGN MATTER EVENT DESCRIPTION MATERIAL: 305196 LOT: 5092808 NO ONE WAS INJURED. HURT. AFFECTED. I OPENED AN UNOPENED HYPODERMIC NEEDLE, AND IT HAS WHITE GUNK ON IT. THE WHITE STUFF IS NORMALLY SECURING THE BASE OF THE NEEDLE BUT THIS ONE HAS LIKE MELTED OR SOMETHING - SPLATTERED. UNSAFE FOR USE ON A PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22884302 ↗
  • MalfunctionAug 20, 2025Material Discolored; Defective Device; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

    NO ONE WAS INJURED/HURT/AFFECTED. I OPENED AN UNOPENED HYPODERMIC NEEDLE, AND IT HAS WHITE GUNK ON IT. THE WHITE STUFF IS NORMALLY SECURING THE BASE OF THE NEEDLE BUT THIS ONE HAS LIKE MELTED OR SOMETHING - SPLATTERED. UNSAFE FOR USE ON A PATIENT. I AM REPORTING IT BECAUSE MAYBE THERE IS A BAD BATCH. 18G X 1 1/2" TW 1.2MMX40MM. REF 305196. ESP 4/30/2030. LOT 5092808. (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22850871 ↗
  • MalfunctionAug 1, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

    IT IS REPORTED INCORRECT LABEL. EVENT DESCRIPTION: MATERIAL#: 305196; BATCH#: 5065323. DESCRIPTION OF CLAIM: PACKING LIST SHOWS 50 CASES OF BATCH 5065323 SHIPPED, HOWEVER UPON INSPECTION WE FOUND ONE CASE DOUBLED LABELED WITH TWO DIFFERENT LOT NUMBERS REFERENCED ON THE EXTERIOR OF THE BOX. SEE ATTACHED PHOTOS FOR THE LABELS SHOWING BATCH 5065323 AND 5065622, THE ACTUAL BATCH SHIPPED IN THE BOX WERE FOR 5065323.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22687507 ↗
  • MalfunctionApr 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    MATERIAL # 305196, BATCH # 4212623, 4270137. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE WHITE PARTICLES ATTACHED TO THE NEEDLES. VERBATIM: WE HAVE FOUND 2 LOTS OF BD PRECISION GLIDE NEEDLES 18G X 1 ½ INCH REF 305196 THAT HAVE WHITE PARTICLES IN THE PACKAGING AND ATTACHED TO THE NEEDLES. THE LOTS ARE 4212623 AND 4270137. THEY WERE RECEIVED FROM XXX. CUSTOMER RESPONSE ON 16-APR-2025. DATE FIRST NOTICED: (B)(6) 2025 FOR BOTH LOTS. COULD YOU PLEASE SPECIFY WHICH LOT NUMBER HAVE "WHITE PARTICLES IN THE PACKAGING AND ATTACHED TO THE NEEDLES" LOT 4212623 AND LOT 4270137.

    Patient problems: Insufficient Information

    MAUDE report 21873078 ↗
  • MalfunctionMar 24, 2025Nonstandard Device; Contamination /Decontamination Problem; Nonstandard Device; Contamination /Decontamination Problem

    MATERIAL # 305196, BATCH # 4247148, 4212625, 3347887. VERBATIM: PATIENT HARM: NO. EVENT DESCRIPTION: WHAT THE CUSTOMERS BEST GUESS IS EXCESS GLUE FOUND UNDER CAP OF 18G PRECISION GLIDE NEEDLE IT WAS IDENTIFIED PRIOR TO USE. I DO HAVE SAMPLES PULLED THAT I CAN MAIL BACK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21675962 ↗
  • MalfunctionMar 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    MATERIAL: 305196. BATCH#: 4270137. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WORK ON THE XXXX. I AM REACHING OUT TO YOU BECAUSE OUR TEAM RECENTLY RECEIVED A SHIPMENT OF PRECISIONGLIDE NEEDLES (ITEM 305196, BATCH 4270137) WHICH HAVE FAILED INCOMING QUALITY INSPECTION DUE TO THE PRESENCE OF PARTICULATES OBSERVED INSIDE THE NEEDLE CAPS WITHIN THE UNOPENED PACKAGING. DURING INVESTIGATION SAMPLE ANALYSIS ON 17 MARCH 2025. "ONE SAMPLE HAS A LOOSE PARTICLE OF EPOXY,".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21646632 ↗
  • MalfunctionFeb 19, 2025Contamination; Contamination

    MATERIAL # 305196. BATCH # 4212625. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE 6 BOXES OF NEEDLES SEQUESTERED. THEY APPEAR TO HAVE A RESIDUE THAT POPS OFF DURING USE. CUSTOMER RESPONSE ON (B)(6)2025. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? NOTICED ANOMALY ON 2-13-2025 - SEQUESTERED INVENTORY. 2. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? 4212625. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 21412860 ↗
  • MalfunctionFeb 5, 2025Gas/Air Leak; Packaging Problem; Gas/Air Leak; Packaging Problem

    MATERIAL # 305196 BATCH # 3320306. RCC RECEIVED A COMPLAINT VIA EMAIL. FAILED LEAK TESTING PERFORMED BY A TEST FACILITY. SKU 305196 BELOW THE RESPONSES TO YOU INQUIRE. PLEASE BE AWARE THAT ONE EVENT INVOLVE THE BUBBLE LEAK FAILURE AND THE OTHER INVOLVE THE PRESENCE OF CHANNELS ON THE SEALING AREA OF THE BLISTER. LET US KNOW IF YOU HAVE ANY ADDITIONAL QUESTIONS OR IF WOULD LIKE TO HAVE A SHORT MEETING TO DISCUSS IN DETAIL. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? RESPONSE: THE FIRST LEAK TEST FAILURE WAS OBSERVED ON (B)(6)2024. SINCE THEN, WE¿VE OBSERVED A FEW MORE FROM THE SAME SAMPLE SET. THE CHANNELS WERE FIRST OBSERVED DURING A VISUAL INSPECTION AT THE ON JANUARY 15TH, 2025. 2. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? RESPONSE: YES. SAMPLES INVOLVING THE PRESENCE OF CHANNELS AND FROM THE BUBBLE LEAK TEST FAILURE FROM THE (WE ARE GETTING THE ADDRESS FOR THE) PLEASE SEND A SHIPPING LABEL FOR THE CHANNEL SAMPLES HERE: NOTE: THE LEAK TEST FAILURE SAMPLES ARE AT THE AND I NEED TO OBTAIN THE CORRECT ADDRESS. PLEASE STANDBY FOR THIS. 3. WAS THE LEAK RELATED TO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21312429 ↗
  • MalfunctionFeb 5, 2025Gas/Air Leak; Packaging Problem; Gas/Air Leak; Packaging Problem

    MATERIAL # 305196 BATCH # 3320306. FAILED LEAK TESTING PERFORMED BY A TEST FACILITY. BELOW THE RESPONSES TO YOU INQUIRE. PLEASE BE AWARE THAT ONE EVENT INVOLVE THE BUBBLE LEAK FAILURE AND THE OTHER INVOLVE THE PRESENCE OF CHANNELS ON THE SEALING AREA OF THE BLISTER. LET US KNOW IF YOU HAVE ANY ADDITIONAL QUESTIONS OR IF WOULD LIKE TO HAVE A SHORT MEETING TO DISCUSS IN DETAILS. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? RESPONSE: THE FIRST LEAK TEST FAILURE WAS OBSERVED ON (B)(6) 2024. SINCE THEN, WE'VE OBSERVED A FEW MORE FROM THE SAME SAMPLE SET. THE CHANNELS WERE FIRST OBSERVED DURING A VISUAL INSPECTION AT THE ON (B)(6) 2025. WAS THE LEAK RELATED TO FLUID LEAK OR AIR LEAKAGE? RESPONSE: LEAK WAS RELATED TO AIR LEAKAGE THAT WAS OBSERVED DURING A BUBBLE LEAK TEST PER ASTM F2096. IN ADDITION, THE PRESENCE OF CHANNELS ON THE SEALING AREA WAS OBSERVED ON UNITS FROM THE SAME LOT THAT WERE SAMPLED FOR EVALUATION (UNTESTED BLISTER PER ASTMF2096 METHOD). WHERE EXACTLY DOES THE LEAKAGE OCCURRED? RESPONSE: AIR LEAKAGE OBSERVED AROUND THE SEALING OF THE BLISTER DURING THE BUBBLE LEAK TEST. IN ADDITION TO THE AIR LEAK, THE PRESENCE OF CHANNELS ON THE BLISTER SEAL

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21312425 ↗
  • MalfunctionFeb 3, 2025Defective Component; Defective Component

    MATERIAL #305196 AND LOT 4212628. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WANTED TO REACH OUT TO REPORT THAT WE HAVE BEEN HAVING AN EXCESSIVE AMOUNT OF VIAL CORING WHEN WE USE THE PRODUCT BELOW. HAS SOMETHING CHANGED WITH THIS PARTICULAR NEEDLE THAT MAY BE IMPACTING THE QUALITY? WE HAVE NOT HAD ANY OTHER CHANGES IN THE MEDICATION PRODUCTS THAT ARE BEING CORED AND ARE WONDERING IF IT COULD BE A NEEDLE MALFUNCTION AT THIS POINT. SOME OF THE RECENT PRODUCTS IDENTIFIED AS BEING CORED WITHIN THE LAST WEEK ARE NOTED BELOW. ALSO NOTE THAT DIFFERENT PEOPLE WERE INVOLVED WITH COMPOUNDING THE DIFFERENT PRODUCTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21290595 ↗
  • MalfunctionDec 19, 2024Defective Component; Defective Component

    NO ADDITIONAL INFORMATION RECEIVED

    Patient problems: Insufficient Information

    MAUDE report 20976792 ↗
  • MalfunctionDec 11, 2024Defective Component; Defective Component

    NO ADDITIONAL INFORMATION RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20902465 ↗
  • MalfunctionDec 11, 2024Defective Component; Defective Component

    NO ADDITIONAL INFORMATION RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20902377 ↗
  • MalfunctionOct 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

    MATERIAL: UNKNOWN BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT HAVE AN 18G NEEDLE WHICH HAS CONTAMINATION AT THE NEEDLE HUB WHERE IT CONNECTS TO A SYRINGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20389576 ↗
  • MalfunctionSep 17, 2024Defective Component; Defective Component

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305196. BATCH#: 3271975. IT WAS REPORTED BY CUSTOMER THAT EVERY USE OF THIS LOT OF NEEDLES IS CAUSING CORING OF THE VIAL AND BAG STOPPERS. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. EMAIL FROM PHSA: HI VENDOR REP, PLEASE FOLLOW UP WITH (B)(6) FOR THE PRODUCT CONCERN OUTLINED BELOW WITHIN 3 BUSINESS DAYS; AND ADVISE OF ANY SPECIAL SHIPPING INSTRUCTIONS FOR PICK UP, COURIER OR DISCARDING OF PRODUCT. PLEASE INVESTIGATE AND FOLLOW UP WITH A WRITTEN REPORT FROM YOUR QUALITY ASSURANCE AS TO YOUR FINDINGS AND RESOLUTIONS. PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6)2024 HOSPITAL: (B)(6). DEPARTMENT: PHARMACY. PRODUCT: PRECISION GLIDE NEEDLE 18G X 1 1/2 IN. VMID: (B)(4) LOT NUMBER: 3271975. PRODUCT EXPIRY DATE: 30-NOV-2028. NUMBER OF DEFECTIVE PRODUCT(S): (B)(4) IS SAMPLE AVAILABLE: YES. CONCERN DESCRIPTION: EVERY USE OF THIS LOT OF NEEDLES IS CAUSING CORING OF THE VIAL AND BAG STOPPERS. THANK YOU IN ADVANCE FOR YOUR FOLLOW-UP ON THIS PRODUCT CONCERN. EMAIL FROM (B)(6): HELLO, WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. (B)(6) REF#(B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALIT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20235640 ↗
  • MalfunctionAug 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    ADDITIONAL INFORMATION RECEIVED ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO, A NEW NEEDLE WAS USED MATERIAL: 305196 BATCH#: 4093950 IT WAS REPORTED BY THE CUSTOMER THAT A TEAM MEMBER WENT TO USE A STERILE 18G NEEDLE, UPON OPENING THE WRAPPER AND UNCAPPING THE NEEDLE, THE NEEDLE LOOKED VISIBLY DIRTY. IT WAS NOT USED IN ANY WAY BESIDES OPENING THE WRAPPER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ON 7/31/24, A TEAM MEMBER WENT TO USE A STERILE 18G NEEDLE, UPON OPENING THE WRAPPER AND UNCAPPING THE NEEDLE, THE NEEDLE LOOKED VISIBLY DIRTY. IT WAS NOT USED IN ANY WAY BESIDES OPENING THE WRAPPER. LOT AND EXP DATE ARE ATTACHED IN THE PICTURES. LET US KNOW IF YOU WOULD LIKE THIS NEEDLE SENT OUT FOR FURTHER INVESTIGATION OR IF IT SHOULD BE PROPERLY DISPOSED OF. PRODUCT NUMBER - 305196. LOT NUMBER - 4093950.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19907702 ↗

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 and updates

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