NA 4468Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403184475), received between Nov 17, 2020 and Feb 4, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT CUSTOMER RECEIVED WET PREP TRAY WITH FOREIGN MATTER. VERBATIM" ¿ I RECEIVED A BD WET PREP PREOPERATIVE SKIN PREP TRAY FROM SAME DAY SURGERY WHILE GETTING READY TO PREP FOR A GYN CASE FOR DR. (B)(6) TODAY, THE NURSE NOTICED A HAIR IN THE BETADINE PREP TRAY, REF# (B)(4), LOT# 004197449, EXP.DATE: 2023-05-31.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13459048 ↗
• MalfunctionNov 9, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED PER CLINICAL DEPARTMENT, THERE IS A HAIR INSIDE THE TRAY. VERBATIM: BY WAY OF THIS EMAIL, WE WOULD LIKE TO FILE THE FOLLOWING PRODUCT COMPLAINT: ITEM: TRAY PREP SKIN WET SCRUB CARE. MANUFACTURER CATALOG #: 4468. LOT #: 0004184317. QUANTITY OF DEFECTIVE PRODUCT: 1 EACH. ISSUES: PER CLINICAL DEPARTMENT, THERE IS A HAIR INSIDE THE TRAY. PLEASE KINDLY FORWARD THIS PRODUCT COMPLAINT TO YOUR COMPANY QA DEPARTMENT APPROPRIATELY. IN ADDITION, PLEASE PROVIDE US WITH INVESTIGATION RESULT REPORT (ONCE IT¿S AVAILABLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778862 ↗
• MalfunctionApr 7, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT GLOVES HAVE HOLES. PER ATTACHED COMPLAINT DETAILS: INCIDENT/NON-CONFORMANCE DESCRIPTION (INCLUDE PHOTO OF NON-CONFORMANCE IF AVAILABLE): THE CUSTOMER REPORTED THE GLOVES INSIDE HAS HOLES IN THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627193 ↗
• MalfunctionMar 29, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE GLOVES HAS HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11583386 ↗
• MalfunctionFeb 23, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE GLOVES HAS HOLES.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 11366685 ↗
• MalfunctionFeb 23, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE GLOVES HAS HOLES.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 11366652 ↗
• MalfunctionJan 21, 2021Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE PRODUCT WERE RECEIVED IN TOTES WITH NO LINERS CAUSING DEBRIS TO GET INSIDE THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11207301 ↗
• MalfunctionNov 17, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE GLOVE HAS HOLES IN A FINGER AND THUMB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10852891 ↗
• MalfunctionNov 17, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE GLOVE HAS A HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10851500 ↗