N/A 305120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903051205), received between Jun 25, 2019 and Feb 1, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT 1 BD PRECISIONGLIDE¿ NEEDLE EACH FROM LOTS 1210597 AND 0252734 WERE DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FINISHED GOOD LOT# PC0236- (BD LOT# 0252734, 1210597)-DATE RECEIVED FROM COMPLAINANT (B)(6) 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280015 ↗
• MalfunctionFeb 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PIECE OF THE NEEDLE 23X1-1/4 RB SYRINGE TIP BROKE OFF WHEN ATTEMPTING TO REMOVE THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE CAP; IMPOSSIBLE TO OPEN/DETACH COULD NOT GET CAP OFF, PIECE OF SYRINGE BROKE. THE NURSE STATED THAT THE SYRINGE BROKE AT THE TIP. THE NURSE STATED THAT THE WHITE COLLAR (OVS) IS NOT ATTACHED TO THE SYRINGE. THE PERSON WHO ADMINISTERED THE PRODUCT WAS A CAREGIVER (NURSE)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11340890 ↗
• MalfunctionMay 20, 2020Break; Break

  IT WAS REPORTED THAT THE CAP WAS HARD TO REMOVE BEFORE USE, AND THE NEEDLE 23X1-1/4 RB BROKE OFF AND PRICKED THE PATIENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REVIEW CASE FOR TPC NEEDLE CAP WAS HARD TO REMOVE ON PRE-FILLED SYRINGES AND NEEDLE WOULD BREAK AND STAB PATIENT. NO OTHER INFORMATION WAS PROVIDED."

  Patient problems: Needle Stick/Puncture

  MAUDE report 10075828 ↗
• MalfunctionMay 19, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE 23X1-1/4 RB WAS DIFFICULT TO REMOVE FROM THE PACKAGING AND HAD TO BE EXTRACTED WITH PLIERS, WHERE IT BROKE DURING THE PROCESS. ADDITIONALLY, IT WAS REPORTED THAT THE NEEDLE LEAKED "AVONEX" FROM THE SYRINGE CONNECTION. ALL DEFECTS OCCURRED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT STATED THEY HAD DIFFICULTY REMOVING NEEDLE FROM PLASTIC PACKAGING. PATIENT ATTEMPTED TO EXTRACT WITH FINGERS BUT WAS UNABLE TO. PATIENT GRABBED PLIERS TO REMOVE NEEDLE FROM PACKAGING. PATIENT STATED THEY HAD TO CLAMP DOWN VERY HARD TO GET ENOUGH FORCE TO PULL THE NEEDLE OUT OF THE PACKAGING. PATIENT ATTACHED NEEDLE TO PRE-FILLED SYRINGE. WHILE INJECTING PATIENT NOTICED MEDICATION LEAKED OUT OF THE POINT WHERE THE NEEDLE ATTACHES TO THE PRE-FILLED SYRINGE AND HAD LEAKED ONTO THE FLOOR. PATIENT DID HAVE 3 MORE PFS ON HAND TO INJECT WITH. CONFIRMED WITH PATIENT THAT IT WAS A 30MCG PRE-FILLED SYRINGE. LOT# PC0136. FOLLOW UP: PATIENT SAID THE NEEDLE WAS IMPOSSIBLE TO REMOVE FROM THE CAP. PATIENT DOES NOT HAVE THE SAMPLE AS SOMEONE CALLED AND TOLD HER TO DISPOSE OF IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10070264 ↗
• MalfunctionJun 25, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD¿ NEEDLE 23X1-1/4 RB CAME WITH A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305120, BATCH NO. 7264645. IT WAS REPORTED TWO DIFFERENT NEEDLES WERE IDENTIFIED IN THE SAME CASE. VERBATIM: DURING PACKAGING OF LQD AVONEX 30MCG ADMIN 4 PK A PACKER IDENTIFIED TWO DIFFERENT NEEDLES IN THE SAME CASE OF PCR-I60005 305120 23 GA ¿ 1 1/4¿ NEEDLES. THE CASE WAS FROM LOT NUMBER 7264645. THE INDIVIDUAL IDENTIFIED THE NEEDLE DIFFERENCE BY THE CAP COLOR AND SIZE DURING PACKAGING. THE ROOM WAS SHUT DOWN PENDING AN INVESTIGATION INTO THE MIXED NEEDLES. BOTH NEEDLES ARE PACKAGED AND LABELED EXACTLY THE SAME ON THE OUTER PACKAGING SLEEVES LQD AVONEX 30MCG ADMIN 4 PK LOT PC0115 HAD A TOTAL OF 506 CARTONS THAT WERE PACKAGED. EACH 4 PK CARTON CONTAINS 4 NEEDLES. THESE CARTONS WILL NEED TO BE RE-WORKED UNDER THE INSTRUCTIONS LISTED IN (B)(4) TO ENSURE THE CORRECT NEEDLE SIZE WAS USED. IN ADDITION ALL OF LOT 7264645 FOR PCR-I60005 WILL BE PLACED ON HOLD UNTIL AN INVESTIGATION IS RECEIVED WITH DISPOSITION OF THE LOT. ANY ADDITIONAL LOTS USED DURING PACKAGING WILL BE INSPECTED PRIOR TO USE FOR MIXED NEEDLES FOR THE REMAINDER OF LOT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731797 ↗

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