N/A 305185Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903051854), received between Dec 13, 2017 and Sep 2, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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.

• MalfunctionSep 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD SAFETY NEEDLES FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAT# 305185 LOT# 1336465. IT WAS REPORTED BY THE CUSTOMER THAT RUBBER RESIDUE IS PULLING INTO THE BOTTLE AND INTO THE DRUG. VERBATIM: IT IS PULLING RUBBER RESIDUE INTO THE BOTTLE & INTO THE DRUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353225 ↗
• MalfunctionJun 20, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED EPOXY ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXCESSIVE MATERIAL THAT KEEPS THE NEEDLE IN PLACE LOCATED ON THE TOP OF THE NEEDLE. APPEARS TO BE THE GOOP USED TO ATTACH THE NEEDLE TO THE HUB ON THE TIP OF THE NEEDLE. INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750111 ↗
• MalfunctionFeb 5, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 2 NEEDLES 18X1-1/2 RB TW EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305185 BATCH NO: 0164132. CUSTOMER REPORTING PRECISION GLIDE NEEDLES WITH A PIECE OF PLASTIC STICKING OUT OF THEM. THEY ALSO FOUND A PIECE OF MATERIAL IN A COMPOUND STERILE PRODUCT AND THEY THINK IT MAY BE A BROKEN OFF PIECE OF PLASTIC FROM OUR NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11285475 ↗
• MalfunctionJan 21, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT A BD PERCISIONGLIDE¿ NEEDLES ARE CORING RUBBER STOPPERS. THIS OCCURRED ON 30 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265439 ↗
• MalfunctionMay 21, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD PERCISIONGLIDE¿ NEEDLE HAD A WHITE SUBSTANCE COVERING THE NEEDLE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531122 ↗
• InjuryDec 13, 2017Device Inoperable

  IT WAS REPORTED THAT DURING USE, A BD PERCISIONGLIDE¿ NEEDLE SAFETY DEVICE MALFUNCTIONED AS AN EMPLOYEE WAS RE-CAPPING AN 18 GAUGE NEEDLE THAT WAS CONNECTED TO AN IV BAGS WITH POTENT API COMPOUND SOLUTION. AS THE EMPLOYEE WAS PUTTING THE CAP ON THE NEEDLE, ¿THE NEEDLE MANAGED TO PUNCTURE THROUGH THE INSIDE OF THE PLASTIC CAP AND OUT OF THE SIDE OF THE CAP INTO HER LEFT THUMB, THIS WAS ENOUGH TO BREAK THE SKIN AND CAUSE A SMALL AMOUNT OF BLEEDING. THE EMPLOYEE¿S CO-WORKERS IMMEDIATELY NOTIFIED EH&S OF THE EMPLOYEE'S INJURY AND WAS ADVISED TO RINSE THE WOUND FOR 15 MINUTES UNDER WATER. THE EMPLOYEE THEN CAME TO EH&S FOR FIRST AID ADMINISTRATION WHICH CONSISTED OF A BANDAGE AND ANTISEPTIC WIPE. THE BLEEDING STOPPED AFTER RINSING AND THE EMPLOYEE'S SYMPTOMS WERE CHECKED THROUGHOUT THE DAY. NO ADDITIONAL SYMPTOMS WERE EXPERIENCED BY THE EMPLOYEE. THE EMPLOYEE WAS OFFERED TO BE TAKEN TO THE MEDICAL CLINIC BUT SHE DENIED THE OFFER SINCE SHE WASN'T EXPERIENCING ANY ABNORMAL EFFECTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture

  MAUDE report 7113282 ↗

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