N/A 305186Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30382903051862), received between Feb 20, 2019 and Jun 26, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 19GA 1IN TW EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305186, BATCH NO: 0022009. RECEIVED AN EMAIL FROM THE CUSTOMER, PROVIDING THE FOLLOWING INFORMATION. THE CUSTOMER CONFIRMED THEY ARE USING A BD NEEDLE. THE PHOTO SAMPLE WAS PROVIDED WITH REF305186. THE LEAKING WAS FOUND OUT WHEN THE NEEDLE WAS DRIPPING AFTER REMOVING THE NEEDLE FROM THE BAG THAT WAS BEING FILLED; THE CLAMP WAS OPEN. THE LOCATION OF THE DRIPPING WAS FROM THE TIP OF THE NEEDLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10199718 ↗
• MalfunctionOct 11, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  MATERIAL NO.: 305186 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE 19GA 1IN TW THE NEEDLE WAS STICKING THROUGH THE CAP PRIOR TO OPENING THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES WAS STICKING THROUGH THE CAP PRIOR TO OPENING THE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178491 ↗
• MalfunctionMay 6, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITH A NEEDLE 19GA 1IN TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 305186, BATCH NO: 8228942. IT WAS REPORTED THAT THE THERE IS WHITE DEBRIS ON THE TIP OF THE NEEDLE. EVENT DESCRIPTION PER SNOW VERBATIM STATES, "THERE IS A WHITE DEBRIS ON THE TIP OF THE NEEDLE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8584359 ↗
• MalfunctionApr 2, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD¿ NEEDLES TW HAD WHITE DEBRIS ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WE ARE STILL SEEING ISSUES WITH OUR BD NEEDLES COMING TO US WITH WHITE DEBRIS ON THEM. EVEN THOUGH LAST TIME, WE WERE TOLD THAT THIS IS NOT A WIDESPREAD ISSUE, WE ARE STILL SEEING THE ISSUE.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8476041 ↗
• MalfunctionFeb 27, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE NEEDLE 19GA 1IN TW EXPERIENCED FOREIGN MATTER CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8374540 ↗
• MalfunctionFeb 27, 2019Leak/Splash

  IT WAS REPORTED THAT A NEEDLE 19GA 1IN TW HAD WHAT APPEARED TO BE AN EXCESSIVE WHITE COMPOUND THAT HAD DRIPPED DOWN THE NEEDLE. THE WHITE COMPOUND ATTACHES/SEALS THE NEEDLE INTO THE BROWN CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8374357 ↗
• MalfunctionFeb 20, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THREE NEEDLE 19GA 1IN TW EXPERIENCED FOREIGN MATTER CONTAMINATION NOTED PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8354043 ↗

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