Safe-T-Centesis PIG1280TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403108402), received between Sep 30, 2021 and Jan 20, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2651-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Packaging Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE SAFE T CENTESIS WIRE IS NOT THREADING THE NEEDLE AND THE COVER DOES NOT FIT.

  Patient problems: Insufficient Information

  MAUDE report 24126423 ↗
• MalfunctionJan 20, 2026Packaging Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE SAFE T CENTESIS WIRE IS NOT THREADING THE NEEDLE AND THE COVER DOES NOT FIT.

  Patient problems: Insufficient Information

  MAUDE report 24126066 ↗
• MalfunctionApr 25, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE SAFE-T-CENTESIS TRAY KIT CATHETER WAS DIFFICULT TO DEPLOY. IT WAS FURTHER REPORTED THAT A PLASTIC PIECE WAS FOUND ON THE TIP OF THE NEEDLE WHEN THE CATHETER WAS PUSHED THROUGH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911513 ↗
• MalfunctionApr 10, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED BY CUSTOMER THAT AFTER FINDING THE NEEDLE OBSTRUCTED, A NEW KIT WAS UTILIZED FOR A NEW NEEDLE. PATIENT HAD TO EXPERIENCE A SECOND ABDOMEN PUNCTURE FOR THE PROCEDURE TO BE COMPLETED. ADDITIONAL EVENT DETAILS REPORTED IN OCCURRENCE BELOW. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTED ISSUE: PATIENT WAS INVOLVED. AFTER FINDING THE NEEDLE OBSTRUCTED, A NEW KIT WAS UTILIZED FOR A NEW NEEDLE. PATIENT HAD TO EXPERIENCE A SECOND ABDOMEN PUNCTURE FOR THE PROCEDURE TO BE COMPLETED. ADDITIONAL EVENT DETAILS REPORTED IN OCCURRENCE BELOW. AFFECTED TRAY HAS BEEN KEPT TO SEND IN FOR INVESTIGATION IF DESIRED BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079702 ↗
• MalfunctionNov 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT CATHETER IS BENDING UPON INSERTION. VERBATIM: OMIT HAS COME TO ME ABOUT THE 8FR CATHETER THAT COMES IN THE SAFET-CENTESIS TRAY ((B)(4)). THE CATHETER HAS BEEN BENDING WHEN IT IS BEING INSERTED IN THE WALL OF THE PATIENT. THIS IS A NEW ISSUE, AND HAS BEEN NOTICED IN THE LAST 3-4 KITS THAT WE HAVE USED. WHEN THIS CATHETER BENDS IT IS HAPPENING INSIDE OF THE PATIENT AND CAUSING THE PATIENT A GREAT AMOUNT OF DISCOMFORT. 10NOV2022: - WHAT WAS THE IMPACT TO THE PATIENT? THE 8FR CATHETER WAS DIFFICULT TO PASS INTO THE ABDOMINAL WALL OF THE PATIENT, EVEN AFTER USING THE 11-BLADE TO MAKE A SMALL INCISION. ON THREE PARTICULAR OCCASIONS, THE METAL CATHETER ACTUALLY BENT BEFORE IT PASSED INTO THE PATIENT. I SUSPECT THIS IS DUE TO THE NEEDLE TIP NOT BEING SHARP ENOUGH AND THEN THE METAL (BEING A LITTLE FLIMSY) NOT BEING ABLE TO SUPPORT THE FORCE. - HOW WAS THE ISSUE RESOLVED? IT WAS ONLY THREE KITS THAT I¿VE NOTICED SO FAR. BUT FOR THOSE THREE PATIENTS, A SEPARATE NEEDLE WAS UTILIZED INSTEAD - WAS THERE A NEED TO REPEAT THE PROCEDURE? NO - IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? THE FAULTY CATHETER WAS DISCARDED ON

  Patient problems: Discomfort

  MAUDE report 15770687 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE SHIELD IS NOT RETRACTING. VERBATIM: BLUNT TIP NEEDLE SHIELD IS SUPPOSED TO RETRACT AND EXPOSE THE NEEDLE, BUT THE SHIELD IS NOT RETRACTING. OCCURRED ON (B)(6) AT 12 O'CLOCK AND ANOTHER (B)(6) AT 1 O'CLOCK. (B)(6) 2022: THERE WERE TWO SEPARATE INCIDENTS. THE FIRST ONE OCCURRED ON (B)(6). HERE ARE THE DETAILS FROM THAT INCIDENT. PATIENT NEEDING A LVP. RESIDENT MD ATTEMPTED LVP BUT AFTER X2 ATTEMPTS, WAS UNABLE TO ACCESS POCKET DESPITE PROVIDING LARGE AMOUNT OF PRESSURE TO NEEDLE AND PATIENT HAVING ROUGHLY 13L OF FLUID IN HIS ABDOMEN. FOLLOWING DAY UPON DISCUSSION W/ ANOTHER MD, SHE NOTED SAME PROBLEM PERFORMING A PARACENTESIS AND NOTED THAT THE BLUNT EDGE OF THE NEEDLE DOES NOT RETRACT TO A SHARP NEEDLE WHEN PRESSURE IS APPLIED WHICH IS LIKELY WHY REPORTERS RESIDENT WAS UNABLE TO ACCESS THE PERITONEUM. LOT # OF PARA KIT 0001434054. THE SECOND INCIDENT OCCURRED ON (B)(6). HERE ARE THE DETAILS FROM THAT INCIDENT. 39 YO MAN WITH ETOH/NASH CIRRHOSIS ADMITTED WITH RECURRENT CULTURE NEGATIVE SBP. TRIED TO DO REPEAT DIAGNOSTIC PARACENTESIS TODAY AND MULTIPLE KITS CONTAINED FAULTY 8 FR SAFE-T-CENTESIS CATHETER DRAINAGE DEVICES. PATIENT SAFETY ISSUE FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007266 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE SHIELD IS NOT RETRACTING. VERBATIM: BLUNT TIP NEEDLE SHIELD IS SUPPOSED TO RETRACT AND EXPOSE THE NEEDLE, BUT THE SHIELD IS NOT RETRACTING. OCCURRED ON (B)(6) AT 12 O'CLOCK AND ANOTHER (B)(6) AT 1 O'CLOCK (B)(6) 2022: THERE WERE TWO SEPARATE INCIDENTS. THE FIRST ONE OCCURRED ON (B)(6). HERE ARE THE DETAILS FROM THAT INCIDENT. PATIENT NEEDING A LVP. RESIDENT MD ATTEMPTED LVP BUT AFTER X2 ATTEMPTS, WAS UNABLE TO ACCESS POCKET DESPITE PROVIDING LARGE AMOUNT OF PRESSURE TO NEEDLE AND PATIENT HAVING ROUGHLY 13L OF FLUID IN HIS ABDOMEN. FOLLOWING DAY UPON DISCUSSION W/ ANOTHER MD, SHE NOTED SAME PROBLEM PERFORMING A PARACENTESIS AND NOTED THAT THE BLUNT EDGE OF THE NEEDLE DOES NOT RETRACT TO A SHARP NEEDLE WHEN PRESSURE IS APPLIED WHICH IS LIKELY WHY REPORTERS RESIDENT WAS UNABLE TO ACCESS THE PERITONEUM. LOT # OF PARA KIT 0001434054. THE SECOND INCIDENT OCCURRED ON (B)(6). HERE ARE THE DETAILS FROM THAT INCIDENT. (B)(6) MAN WITH ETOH/NASH CIRRHOSIS ADMITTED WITH RECURRENT CULTURE NEGATIVE SBP. TRIED TO DO REPEAT DIAGNOSTIC PARACENTESIS TODAY AND MULTIPLE KITS CONTAINED FAULTY 8 FR SAFE-T-CENTESIS CATHETER DRAINAGE DEVICES. PATIENT SAFETY ISSUE FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007051 ↗
• MalfunctionSep 30, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CAP WAS LOOSE AND SEPARATED AND THE SYRINGE DID NOT EJECT THE PRODUCT INTO THE PATIENT. REPORTED ISSUE: SCREW CAP WAS LOOSE AND FELL OFF AND ON TO THE GROUND. THE PRODUCT CAP NORMALLY COMES PRETTY TIGHT. THE THIRD ONE THE SYRINGE DID NOT EJECT THE PRODUCT INTO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555668 ↗