PIVO 22G 202-0006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850984007034), received between Jan 11, 2024 and Sep 3, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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.

• MalfunctionSep 3, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT BD PIVO BLOOD COLLECTION DEVICE POUCH COMPROMISED BY UNKNOWN LIQUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) RECEIVED SOME BOXES OF PIVO DEVICES THAT LOOKED AND SMELLED LIKE THEY HAD BEEN SOAKED IN MOTOR OIL OR SOMETHING OF THAT SORT. THE BOXES THEMSELVES FEEL GREASY, AND WHATEVER IT IS IT¿S CLEARLY SOAKED ALL THE WAY THROUGH THE CARDBOARD AND INTO THE PACKAGING OF THE PIVO DEVICES THEMSELVES. OBVIOUSLY, WE DON¿T FEEL COMFORTABLE USING THESE DEVICES ON PATIENTS. WE RECEIVED ONE CASE THAT WE INTEND TO DISCARD ENTIRELY DUE TO THE DAMAGE TO THE BOXES INSIDE. 15AUG2024 ¿ WHAT IS THE ACTUAL ISSUE OF PIVO CARDBOARD CASE CONTAINING BOXES OF PIVO DEVICES IS SOAKED WITH CHEMICAL/MOTOR OIL. THE POLLUTANT WAS ABSORBED THROUGH THE CARDBOARD COMPLETELY AND SOAKED INTO THE PACKAGED PIVO DEVICES INSIDE. ¿ ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO, WE REALIZED THERE WAS A PROBLEM AND DID NOT PUT ANY OF THE DEVICES INTO USE. BOXES WERE PLACED ASIDE UPON RECEIPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130397 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTION: THE MATERIAL NUMBER WAS INCORRECTLY DOCUMENTED AT INTAKE AND HAS BEEN CORRECTED TO BE "201-0006".

  Patient problems: Insufficient Information

  MAUDE report 18497998 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTION: THE MATERIAL NUMBER WAS INCORRECTLY DOCUMENTED AT INTAKE AND HAS BEEN CORRECTED TO BE "201-0006".

  Patient problems: Insufficient Information

  MAUDE report 18497532 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTION: THE MATERIAL NUMBER WAS INCORRECTLY DOCUMENTED AT INTAKE AND HAS BEEN CORRECTED TO BE "201-0006".

  Patient problems: Insufficient Information

  MAUDE report 18497509 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BD PIVO BLOODCOLLECTON USED ON PATIENT WHO WAS DIAGNOSED WITH AN INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPRESENTATIVES OF ALLEGHENY HEALTH NETWORK HAVE MADE VERBAL COMMENTS WITH CONCERNS OF INCREASED INFECTIONS IN PATIENTS MATERIAL 1: 202-0006 LOT: 100322-03

  Patient problems: Insufficient Information

  MAUDE report 18496749 ↗