N/A 4540ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403143243), received between Feb 3, 2022 and May 7, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 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.

• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A SERIOUS PATIENT SAFETY EVENT INVOLVING THE SPONGES INCLUDED IN THE TRAY. VERBATIM: SRG ¿ VH ¿ LOT:0001394825 - SERIOUS PATIENT SAFETY EVENT INVOLVING THE SPONGES. I AM THE RISK MANAGER AT MEDICAL CENTER, A PART OF *** HEALTHCARE. WE HAD A RECENT SERIOUS PATIENT SAFETY EVENT INVOLVING THE SPONGES INCLUDED IN YOUR PARACERVICAL/PUDENDAL BLOCK TRAY (CAT 4540A). ADDITIONALLY, ANOTHER HOSPITAL WITHIN OUR SYSTEM, HOSPITAL, HAD A SIMILAR EVENT. WE WOULD LIKE TO DISCUSS AND EXPLORE OPTIONS TO NOT INCLUDE THE 2 SPONGES IN THIS TRAY. PLEASE CONTACT ME AT YOUR EARLIEST CONVENIENCE TO DISCUSS THIS MATTERS, AS IT HAS SIGNIFICANT IMPACT ON OUR PATIENT SAFETY PRACTICES AT (B)(4) HEALTHCARE.

  Patient problems: Insufficient Information

  MAUDE report 14321407 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A SERIOUS PATIENT SAFETY EVENT INVOLVING THE SPONGES INCLUDED IN THE TRAY. VERBATIM: SRG ¿ VH ¿ LOT:0001394825 - SERIOUS PATIENT SAFETY EVENT INVOLVING THE SPONGES. I AM THE RISK MANAGER AT MEDICAL CENTER, A PART OF *** HEALTHCARE. WE HAD A RECENT SERIOUS PATIENT SAFETY EVENT INVOLVING THE SPONGES INCLUDED IN YOUR PARACERVICAL/PUDENDAL BLOCK TRAY (CAT 4540A). ADDITIONALLY, ANOTHER HOSPITAL WITHIN OUR SYSTEM, HOSPITAL, HAD A SIMILAR EVENT. WE WOULD LIKE TO DISCUSS AND EXPLORE OPTIONS TO NOT INCLUDE THE 2 SPONGES IN THIS TRAY. PLEASE CONTACT ME AT YOUR EARLIEST CONVENIENCE TO DISCUSS THIS MATTERS, AS IT HAS SIGNIFICANT IMPACT ON OUR PATIENT SAFETY PRACTICES AT (B)(6) HEALTHCARE.

  Patient problems: Insufficient Information

  MAUDE report 14320813 ↗
• MalfunctionFeb 3, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT NEEDLES WERE BENT AND WOULD NOT ALLOW MEDICATION TO BE INJECTED INTO PATIENT. DETAILS OF COMPLAINT (REPORTED ISSUE): OUR PHYSICIAN(S) OPENED A CAREFUSION ¿PARACERVICAL/PUDENDAL BLOCK TRAY¿ LOT#: 0001356845 EXP#: 2025/03/21 AND WHEN THEY DID THEY NOTICED THAT THE 20G X 6¿ (15.2CM) NEEDLE WITH SPACER HAD A 30 DEGREE BEND AT THE CUFF. IN ADDITION TO THE BEND, SHE WAS ABLE TO DRAW UP MEDICATION WITH THE NEEDLE/SYRINGE, BUT THE SYRINGE WOULDN'T ALLOW THE MEDICATION TO BE INJECTED INTO THE PATIENT. AT THE TIME THE PHYSICIAN PUT THE TRAY TO THE SIDE AND OPENED 2 MORE, ALL OF WHICH HAD THE SAME ISSUE, SO THEY INITIALLY THOUGHT IT MIGHT BE A DESIGN CHANGE OF THE TRAY, BUT WHEN THEY REALIZED THAT ALL THREE SYRINGES WOULDN'T ALLOW FOR MEDICATION TO BE INJECTED THERE WAS AN ISSUE. PATIENT INJURY: NO. PER EMAIL (B)(6) 2022. I DID HAVE THE DISCUSSION WITH THE PHYSICIANS THAT WERE INVOLVED IN THE INCIDENT, AND THERE WAS A DELAY IN PROVIDING PAIN RELIEF TO A PATIENT FOR APPROX. 10 MINUTES, AS THE SYRINGE/NEEDLE WASN'T WORKING PROPERLY WITH THE BEND, AS WELL AS THE TIME IT TOOK TO OPEN ADDITIONAL PACKAGES AND SET THEM UP REPEATEDLY. I DO HAVE THE BOX OF SAMPLES, AND PHOTOS IF Y

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442142 ↗