N/A 305199Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382903051991), received between Nov 1, 2017 and Jul 17, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DESCRIPTION: EPOXY ON NEEDLE. EVENT DETAILS: SEVERAL NEEDLES WITH A LARGE GLOB OF DRIED WHITE MATERIAL WHERE THE METAL PART OF THE NEEDLE ATTACHES TO THE PINK HUB. MATERIAL # 305199, BATCH # 1027259.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531141 ↗
• MalfunctionSep 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE 18X1-1/2 SB PULLED OUT OF HUB. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305199; BATCH NO: 9269108. IT WAS REPORTED THAT: NEEDLE PULLED OUT OF HUB. EVENT DESCRIPTION PER EMAIL STATES: "OBTAINING MEDICATION PRE-PROCEDURE, RN ATTACHED A PINK NEEDLE TO A SYRINGE AND INSERTED SYRINGE INTO MEDICATION AND THE NEEDLE SEPARATED FROM THE PINK HUB WHICH WAS CRACKED AND THE NEEDLE REMAINED IN THE MEDICATION." THE MEDWATCH REPORTED WAS RECEIVED IN FRANKLIN LAKES ON (B)(6) 2020 AND IT REFLECTED IN THE AWARENESS DATE. THE REPORT WAS NOT SENT TO THE RCC UNTIL (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10564236 ↗
• MalfunctionApr 22, 2020Material Separation

  OBTAINING MEDICATION PRE-PROCEDURE, RN ATTACHED A PINK NEEDLE TO SYRINGE AND INSERTED SYRINGE INTO MEDICATION AND THE NEEDLE SEPARATED FROM THE PINK HUB WHICH WAS CRACKED AND THE NEEDLE REMAINED IN THE MEDICATION.

  Patient problems: No Patient Involvement

  MAUDE report 9985686 ↗
• MalfunctionJul 10, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE RED FOREIGN MATTER WAS DISCOVERED ON NEEDLE WITH A BD NEEDLE 18X1-1/2 SB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE WAS CONTAMINATED WITH A RED SUBSTANCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8776293 ↗
• MalfunctionJun 25, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE NEEDLE COULD NOT ATTACH TO SYRINGE, EITHER HUB TOOL SHORT OF NEEDLE CAP TOO LONG, ALSO, THE HUB WAS A DIFFERENT COLOR THAN THE REST OF THE LOT NUMBERS WITH A BD NEEDLE 18X1-1/2 SB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305199 BATCH NO. 8117703 . IT WAS REPORTED THAT THE NEEDLE WOULD NOT ATTACH TO THE SYRINGE AND IT WAS NOTED THAT THE NEEDLE HUB WAS A DIFFERENT COLOR FROM THE REST OF THE LOT NUMBERS. PER INITIAL REPORTER EMAIL: ¿ COULD NOT ATTACH THE NEEDLE TO THE SYRINGE. IT APPEARS THE HUB IS TOO SHORT OR THE NEEDLE CAP IS TOO LONG AND THERE IS NO SPACE TO ACCOMMODATE THE ATTACHING OF THE HUB TO THE TIP OF THE SYRINGE. THE NEEDLE HUB IS A DIFFERENT COLOUR THAN OTHERS OF THE SAME LOT NUMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732365 ↗
• MalfunctionJun 12, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT NEEDLE SHIELD PENETRATION OCCURRED WITH A NEEDLE 18X1-1/2 SB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE STICKING THROUGH CAP CAUSING NEEDLE STICK."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8693202 ↗
• MalfunctionJun 14, 2018Fail-Safe Problem

  LATE AT NIGHT, THIS RN WAS IN THE PATIENT'S ROOM TO GIVE PRN ATIVAN TO A PATIENT. ATIVAN INITIALLY DRAWN UP INTO A 10CC SYRINGE, IN PREPARATION TO RETRACT THE NEEDLE, THE HINGE OF THE NEEDLE PROTECTOR BECAME LIMP AND THE NEEDLE WAS UNABLE TO BE CAPPED. NEEDLE WAS UNABLE TO BE REMOVED SAFELY FROM THE SYRINGE. NO NEEDLE STICKS OCCURRED IN THIS EVENT. NEEDLE/SYRINGE IS CURRENTLY IN A PLASTIC URINAL FOR INSPECTION. TO BE GIVEN TO MANAGER IN THE MORNING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7600678 ↗
• MalfunctionNov 1, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON A BD PRECISIONGLIDE¿ NEEDLE 18 G X 1 1/2 IN. THE PRODUCT WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6994914 ↗

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