Vented Needle 415072Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04022495769893), received between May 14, 2020 and Jul 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060442 ↗
• MalfunctionApr 17, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS PER MEDWATCH IT WAS REPORTED: DESCRIPTION: WE HAVE HAD MULTIPLE EVENT REPORTS OF PHARMACISTS NOTING PARTICULATE IN DAPTOMYCIN PREPARATIONS WITH THE DAPTOMYCIN FOR INJECTION 500MG/VIAL XELLIA PHARMACEUTICALS NDC 70594-034-01 PRODUCT. WITH FURTHER INVESTIGATION IT APPEARS THIS WAS NOT LIMITED TO A CERTAIN INDIVIDUAL WHO WAS COMPOUNDING AND OCCURRED MULTIPLE DATES AND TIMES WITH, VARIOUS LOT NUMBERS AT DIFFERENT SITES ACROSS OUR HEALTH SYSTEM. THE MANUFACTURE NOTES NEED TO USE CERTAIN PRODUCTS TO COMPOUND THIS PRODUCT INCLUDING A 21G NEEDLE WHICH IS SMALLER THAN STANDARD NEEDLES USED FOR COMPOUNDING OR A VENTED NEEDLE FROM BBRAUN (REF 415072). OUR SITE HAS USED BOTH DEVICES A 21G NEEDLE AND THE VENTED NEEDLE RECOMMENDED BY THE MANUFACTURE WITH CONTINUED CONCERNS OF CORING REPORTED VISIBLE TO THE EYE. LUCKILY THESE HAVE BEEN NEAR MISS EVENTS CAUGHT BY OUR PHARMACIST PRIOR TO REACHING THE PATIENTS WITH NO HARM NOTED TO PATIENTS, HOWEVER, IS STILL OF CONCERN. WE HAVE ALERTED THE MANUFACTURE AND THEY NOTED THEY DID NOT FIND ANY INTERNAL ISSUES WITH THE PRODUCT GIVEN THE CONSISTENT CONCERNS WE NOW HAVE THE TECHNICIANS FILTER THIS PRODUCT AT OUR SITE PRIOR TO DISPENSING. NO INJURY REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751147 ↗
• MalfunctionMay 14, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: END USER REPORTS THAT A BROWN SPECK WAS NOTED ON THE HUB. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10055800 ↗