NA 4461ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403142192), received between Feb 17, 2021 and Jan 6, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL NO.: 4461A, BATCH NO.: 0004177456. IT WAS REPORTED THAT DEBRIS WAS FOUND INSIDE TRAYS. VERBATIM: (B)(6), ''NOT ENOUGH INFORMATION PROVIDED'' HELLO PLEASE SEE THE PIC BELOW. THIS ITEM WAS SENT FROM OUR LOCAL WAREHOUSE (B)(6). AS BECTON DICKINSON IS THE MANUFACTURER I FELT THAT IT WAS IMPORTANT ENOUGH TO SHARE WITH YOU THAT THESE CAME IN UNSTERILE. DEBRIS HAS BEEN FOUND IN THESE TRAYS LOT # 0004177456.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180107 ↗
• MalfunctionJul 1, 2021Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTOR THAT DEBRIS FOUND ON OUTSIDE OF STERILE WRAPPER. DEBRIS ON OUTSIDE STERILE WRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099650 ↗
• MalfunctionApr 20, 2021Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  MATERIAL NO: 4461A, BATCH NO: 0004165631. IT WAS REPORTED THAT A BUG WAS FOUND INSIDE OF THE KIT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: I HOPE THINGS ARE WELL. I RECEIVED A PRODUCT COMPLAINT A MOMENT AGO CONCERNING A BUG FOUND IN THE CUSTOMER BELOW'S PREP KIT. LOT NUMBER, PREP TRAY NUMBER, ETC IS ALL INCLUDED BELOW. LYNN WHO IS THE CUSTOMER AT THE ACCOUNT WHO LET US KNOW OF THE ISSUES EMAIL IS L[OMITTED] THE PRODUCT WAS NOT USED AN IMMEDIATELY DISCARDED. THANKS FOR ANY ASSISTANCE YOU CAN PROVIDE. HAVE A WONDERFUL DAY. YES, YOU READ THAT RIGHT. TODAY WE FOUND A BUG IN OUR PREP KIT. IT LOOKS TO HAVE BEEN STERILIZED ALONG WITH THE KIT AS IT WAS FOUND UNDER THE SPONGE STICKS, HOWEVER, WE CHOSE NOT TO USE IT. DOES THIS GET FORWARDED TO BD? HOW DOES SOMETHING LIKE THIS GET HANDLED?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697091 ↗
• MalfunctionApr 20, 2021Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  MATERIAL NO.: 4461A, BATCH NO.: 0004173982. IT WAS REPORTED THAT A HAIR WAS FOUND IN THE TRAY BEFORE USE. PER EMAIL: CAN YOU FORWARD THIS QUALITY ISSUE TO THE BD REP. OR FOUND A HAIR IN THE DRY PREOP SKIN PREP TRAY. ECH # 007202, REF# 4461A, LOT # 004173982. IT WAS ATTACHED TO ONE OF THE SPONGE STICKS. SEE BELOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11696909 ↗
• MalfunctionFeb 17, 2021Device Dislodged or Dislocated

  IN PREPARATION FOR A C-SECTION, THE RN PERFORMED A VAGINAL CLEANSE USING THE BD SKIN PREP TRAY. SHE SOAKED THE SPONGE STICKS (2) IN BETADINE AND PUT TWO TOGETHER AND INSERTED THEM INTO PT'S VAGINA. SHE WAITED 15 SECONDS AND THEN REMOVED BOTH SPONGE STICKS AND DISPOSED OF THEM INTO THE BASIN AT THE BASE OF PT'S VAGINA AND THREW THEM AWAY. THE PATIENT HAD AN EPIDURAL SO DID NOT FEEL ANYTHING. THE PHYSICIAN PERFORMED A FUNDAL MASSAGE AT THE END OF THE PROCEDURE AND THE USUAL AMOUNT OF VAGINAL DISCHARGE/BLOOD WAS SEEN COMING FROM THE VAGINA WITHOUT ANYONE SEEING THE SPONGE WHICH HAD BECOME DISLODGED FROM ONE OF THE STICKS AND REMAINED IN THE VAGINA. THE PATIENT WAS DISCHARGED ON (B)(6) 2020 W/O COMPLAINT OF VAGINAL PRESSURE, PAIN, OR ODOR. THE PATIENT HAD BEEN SEEN BY AN OUTPATIENT HEALTH PROVIDER VIA TELE-VIDEO AND REPORTED HAVING SOME ONGOING LABIA SWELLING AND DISCOMFORT BUT DECLINED TO MAKE AN APPOINTMENT AT THAT TIME ((B)(6) 2021). ON (B)(6) 2021, THE PT CALLED HER PROVIDER'S CLINIC AND ASKED TO MAKE AN APPOINTMENT AS SHE WAS NOW FEELING SOME PRESSURE IN HER VAGINAL AREA AND SMELLING A STRONG ODOR. THE PROVIDER ASKED IF HAD PAIN SHE DENIED BUT SHE DID REPORT SHE FELT INTO HER VAGI

  Patient problems: Abnormal Vaginal Discharge; Discomfort; Erythema; Foreign Body In Patient; Swelling/ Edema

  MAUDE report 11343308 ↗