Safe-T TPT1000SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403108433), received between Jul 9, 2020 and Nov 18, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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-2656-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Contamination; Contamination

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS DEBRIS IN ONE OF THE TEST TUBES IN THE KIT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED NOTICED THAT THERE WAS DEBRIS IN ONE OF THE TEST TUBES IN THE KIT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PARACENTESIS. PRODUCT NUMBER - TPT1000SP CUSTOMER RESPONSE ON NOV 11, 2024 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE DEBRIS? NO ADDITIONAL INFORMATION PROVIDED. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? AFTER COMPLETING PROCEDURE. 3. WHAT WAS THE IMPACT TO THE PATIENT? NONE 4. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 5. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 08-19-2024 6. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE?0001569804 7. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708380 ↗
• MalfunctionNov 1, 2024

  NOTICED THAT THERE WAS DEBRIS IN ONE OF THE TEST TUBES IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587064 ↗
• MalfunctionJul 18, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE INTRODUCER NEEDLE BROKE DURING THE PROCEDURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE INTRODUCER NEEDLE BROKE DURING THE PROCEDURE. THEY HAD TO OPEN ANOTHER TRAY TO COMPLETE THE PROCEDURE. PRODUCT NUMBER - TPT1000SP. LOT NUMBER - 00018559052. DESCRIBE PATIENT / HCP / USER IMPACT - OPENED ANOTHER TRAY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771467 ↗
• InjuryNov 17, 2022Component Missing; Component Missing

  IT WAS REPORTED BY THE CUSTOMER THAT THE STOP COCK TURN DIAL WAS MISSING AND WHEN THE PHYSICAL PUNCTURE OCCURRED IT ALLOWED AIR INTO THE CAVITY CAUSING PATIENT HARM. PRODUCT NAME: SAFE-T PLUS THORA-PARA TRAYS. PATIENT HARM: IT WAS MISSING THE STOP COCK TURN DIAL, SO WHEN THE PHYSICAL PUNCTURE AND IT ALLOW THE AIR IN THE CAVITY CAUSING HARM TO THE PATIENT. PATIENT HARM REQUIRE FURTHER INTERVENTION: A TUBE. DATE OF EVENT: (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 14-NOV-2022. WHAT WAS THE PROCEDURE BEING PERFORMED? THORACENTESIS. WAS THERE PATIENT HARM/IMPACT? YES, PATIENT REQUIRED CHEST TUBE PLACEMENT NEXT DAY DUE TO PNEUMOTHORAX, AND THEN LATER TRANSFER TO HLOC FOR CARDIOTHORACIC SURGERY. WAS THE PROCEDURE ABLE TO BE COMPLETED, WHAT WAS DONE TO COMPLETE IT? YES, A NEW KIT WAS OPENED TO OBTAIN THE SUPPLY WITH STOPCOCK IN PLACE. DO YOU HAVE ANY PHOTOS SHOWING THE REPORTED ISSUE.? YES. PLEASE USE THE ATTACHED PREPAID SHIPPING LABEL TO RETURN THE AFFECTED PRODUCT. OUR QUALITY DEPARTMENT WILL RETAIN THE DEFECTIVE UNIT AS IT WAS USED FOR PATIENT CARE PRIOR TO THE DISCOVERY OF MISSING PIECES AND DID CAUSE HARM TO THE PATIENT.

  Patient problems: Pneumothorax

  MAUDE report 15818285 ↗
• MalfunctionJun 16, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLES BROKE. VERBATIM: SRG ¿ VH - TPT1000SP ¿ LOT: 0001449441 - DURING THE CASE THE NEEDLE BROKE OFF. THIS AFTERNOON DR. (B)(6) WAS PREFORMING A THORACENTESIS AND DURING THE CASE THE NEEDLE BROKE OFF. HE THEN PROCEEDED TO GET ANOTHER THORACENTESIS KIT, IN WHICH THE NEEDLE IN THAT KIT BENT AS HE WAS PERFORMING THE PROCEDURE. I'M UNSURE IF IT IS A SPECIFIC LOT OF THESE CAREFUSION THORA/PARA KITS, BUT, I WANTED TO BRING IT TO EVERYONE'S ATTENTION. WAS THE BROKEN NEEDLE AND THE BENT NEEDLE OBSERVED BEFORE USE OR DURING THE USE ON PATIENT? WE USED TWO KITS. WITH THE FIRST KIT THE JOINT WHERE THE NEEDLE AND THE SYRINGE MEET FELT FLIMSY WHICH WAS UNUSUALLY. I STRONGLY SUSPECT THE NEEDLE WAS BENT PRIOR TO USE BUT DID NOT DIRECTLY OBSERVE. WITH THE SECOND KIT, AGAIN THE CATHETER HUB WAS NOT FLUSH AND THIS TIME I DID OBSERVE THAT THE NEEDLE WAS BENT BEFORE USE, BUT WAS STILL PATENT AND OTHERWISE FUNCTION. WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? THROACENTESIS. HOW WAS ITEM PIECE RETRIEVED FROM PATIENT/PROCEDURE? THE NEEDLE BROKE AFTER WE HAD REMOVED IT FULLY FROM THE PATIENT. THERE WAS PLEURAL FLUID LEAKING FROM THE POINT WHERE THE NEEDLE MEETS THE SYRINGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712655 ↗
• MalfunctionJul 9, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE SAFE-T PLUS THORACENTESIS/PARACENTESIS CATHETER LEFT IN THE PATIENT WAS "TOO FLEXIBLE/PLIABLE" AFTER REMOVING THE NEEDLE, REQUIRING AN INCISION TO OBTAIN APPROPRIATE DRAINAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THEIR REPORT THE CATHETER THAT IS LEFT IN THE PATIENT AFTER REMOVING THE NEEDLE IS TOO FLEXIBLE/PLIABLE. THIS CAUSES THE PHYSICIAN TO HAVE TO USE 2 SOMETIMES 3 KITS TO GAIN APPROPRIATE ACCESS. IT WAS NOTED ESPECIALLY WHEN USING THE PRODUCT FOR PARACENTESIS THEY OFTEN HAVE TO MAKE AN INCISION TO OBTAIN APPROPRIATE DRAINAGE WHEREAS WITH PRIOR PRODUCTS NO INCISION WAS REQUIRED. THIS INCREASES THE RISK FOR BLEEDING AND LEAKAGE. THE PRESSURE OF THE ADIPOSE LAYER OCCLUDES THE CATHETER DUE TO ITS EXTREME FLEXIBILITY MAKING THE PRODUCT INEFFECTIVE FOR ITS INTENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10253603 ↗