BD IV Start Pak, BD Persist 386170Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30382903861706), received between Nov 5, 2018 and Aug 14, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD IV START PAK¿ EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1BX (25EA) FOUND HAVING LEAKAGE UPON DELIVERY TO CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545750 ↗
• MalfunctionAug 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD IV START PAK¿ EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS DETECTED THAT ONE PRODUCT IS EXPERIENCING A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435580 ↗
• MalfunctionDec 18, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT IV START PAK W/PERSIST, TEGADERM CAME BROKEN AND HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMES BROKEN AND STAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489586 ↗
• MalfunctionJun 27, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE IT WAS NOTICED THAT THE PERSIST PACKAGE LEAKED IN START PAK WITH A BD IV START PAK W/PERSIST, TEGADERM. THIS OCCURRED WITH 3 SEPARATE IV START PAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: 3 PIECES ARE STAINED AS THE ENVELOPE IS BROKEN WITH IODINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739516 ↗
• MalfunctionNov 5, 2018Leak/Splash

  IT WAS REPORTED WITH THE USE OF THE BD IV START PAK¿ SITE PREP KIT WITH BD PERSIST¿ SKIN PREP, TEGADERM® DRESSING THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8039304 ↗