N/A 305115Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30382903051152), received between Mar 20, 2018 and Jul 6, 2023 — classified as 4 injuries, 2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2023Break; Break

  IT WAS REPORTED WHILE USING BD SAFETY NEEDLE THE NEEDLE BROKE OFF IN PATIENTS NECK. NEEDLE WAS UNABLE TO BE REMOVED, FLUOROSCOPY, ULTRASOUND, AND CT SCAN PERFORMED, SURGERY RECOMMENDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING PATIENT PRESENTED TO THE CHRONIC PAIN CLINIC FOR A TRIGGER POINT INJECTION. UNFORTUNATELY, DURING THE PROCEDURE THE NEEDLE BROKE INSIDE THE PATIENT'S NECK. IMMEDIATE ATTEMPTS WERE MADE AT THE BEDSIDE TO RETRIEVE THE BROKEN NEEDLE BUT WERE UNSUCCESSFUL. WITH PATIENT CONSENT, RETRIEVAL OF THE FOREIGN OBJECT IN THE FLUOROSCOPY ROOM WHERE BOTH FLUOROSCOPY AND ULTRASOUND WAS USED TO LOCATE THE NEEDLE, BUT NOT POSSIBLE. VASCULAR SURGERY WAS CONSULTED AND CT SCAN WAS RECOMMENDED SOMETIMES THIS WEEK FOR THE REMOVAL. ALL NEEDLES WITH THE SAME LOT NUMBER AS THE ONE USED WERE IMMEDIATELY REMOVED FROM SERVICE. NURSE MANAGER AND DIRECTOR NOTIFIED OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17276161 ↗
• MalfunctionMay 30, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD SAFETY NEEDLES HAD AN ADDITIONAL NEEDLE CAUSING IT TO PROTRUDE FROM THE PLASTIC SAFETY CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD AN ISSUE WITH PRODUCT 305115 26GAX5/8 HYPO NEEDLE LOT NUMBER 2056622. THE NEEDLE WAS MANUFACTURE WITH 2 NEEDLES WHICH CAUSED ONE OF THE NEEDLES TO PROTRUDE FROM THE PLASTIC SAFETY CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17025163 ↗
• InjurySep 21, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE PENETRATED THROUGH THE SHIELD AND CAUSED A NEEDLESTICK INJURY TO THE NURSE. THIS OCCURRED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:305115 BATCH NO: 7285614. IT WAS REPORTED THAT A NURSE WAS STUCK WITH A NEEDLE. VERBATIM: NURSE ADMINISTERED SUBCUTANEOUS MEDICATION AND RE-CAPPED THE NEEDLE UTILIZING THE SCOOP METHOD. THE NURSE THEN PROCEEDED TO PUSH ON THE NEEDLE CAP TO FIRMLY SECURE IT TO THE NEEDLE HUB AND DID NOT REALIZE THAT THE NEEDLE HAD PENETRATED THE CAP, WHICH RESULTED IN A NEEDLE STICK TO THE NURSE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10564175 ↗
• MalfunctionJan 24, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AN EXTRA NEEDLE 26X5/8 RB WAS FOUND PIERCED THROUGH THE NEEDLE COVER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AN EXTRA NEEDLE IS WITHIN THE CAP OF THE EXISTING NEEDLE AND IS POKING OUT THE TOP".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9630109 ↗
• InjuryOct 30, 2018Fail-Safe Problem

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE, SUB-Q PIERCED THROUGH THE CAP AND RESULTED IN A CONTAMINATED NEEDLE STICK. THE DOCTOR AND PATIENT WERE REPORTED TO HAVE BEEN TESTED FOR "ANY COMMUNICABLE DISEASES AND ARE NEGATIVE SO FAR".

  Patient problems: Needle Stick/Puncture

  MAUDE report 8019303 ↗
• InjuryMar 20, 2018Break

  IT WAS REPORTED THAT AFTER A PATIENT¿S SUB-Q INJECTION, THE NEEDLE OF A BD PRECISIONGLIDE¿ NEEDLE, SUB-Q BENT AND BROKE OFF. THIS CAUSED THE USER TO RECEIVE A DIRTY NEEDLE STICK.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 7355420 ↗

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