Safe-T OTP5000SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403470820), received between Jan 8, 2021 and Feb 15, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. HAVE YOU HEARD ANY OTHER COMPLAINS OR ISSUES RELATED TO THIS?

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712387 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. HAVE YOU HEARD ANY OTHER COMPLAINS OR ISSUES RELATED TO THIS? FOLLOW-UP: CUSTOMER RESPONSE ON (B)(6) 2024 : 1. CAN YOU PLEASE PROVIDE A EXACT DATE OF EVENT? I DO NOT HAVE EXACT DATES. I JUST KNOW IT HAS OCCURRED A FEW SEPARATE TIMES WITH 3 DIFFERENT PHYSICIANS REPORTING ISSUES. 2. TOTAL NUMBER OF EVENTS? (B)(4). 3. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? IF YES, WHAT WAS THE IMPACT TO THE PATIENT? YES, THIS OCCURRED DURING PROCEDURES. IT R

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712385 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. HAVE YOU HEARD ANY OTHER COMPLAINS OR ISSUES RELATED TO THIS?

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712219 ↗
• MalfunctionSep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT NEEDLE IS LEAKING FLUID. PER COMPLAINT DETAILS RECEIVED: WE ARE STILL HAVING ISSUES/ CONCERNS WITH THIS PRODUCT AND LEAKING OF FLUID AND THE RADIOLOGIST ARE REQUESTING SOMEONE TO COME ASSIST US AND THEY PREFER A VALVED NEEDLE THAT DOES NOT LEAK FLUIDS BEFORE CONNECTING TO THE TUBING. IT WAS ALSO MENTIONED THEY ARE BEING EXPOSED TO BODILY FLUIDS. PER FOLLOW-UP : THIS KIT CONTAINS A "NON VALVE CATHETER". THERE IS NO WAY TO STOP FLUID FROM LEAKING FROM IT. IT IS A SAFETY RISK TO THE PATIENTS AND TO THE STAFF AS WE ARE BEING EXPOSED TO BODY FLUID. IT IS NOT FAULTY, IT IS THE WRONG CATHETER FOR THE PROCEDURE. THE KIT IS ADEQUATE AND WILL WORK FINE IF THE CATHETER IS CHANGED OUT TO A "VALVE" CATHETER. IT IS EXACTLY THE SAME SIZE AND STYLE- BUT HAS A SAFETY VALVE TO KEEP THE FLUID FROM LEAKING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12536474 ↗
• MalfunctionJan 8, 2021Break; Break

  MATERIAL NO: OTP5000SP; BATCH NO: UNKNOWN. IT WAS REPORTED THAT CATHETER BROKE OFF ITS BASE WHILE REMOVING CATHETER FROM PATIENT AS WE NORMALLY REMOVE WHEN COMPLETING PROCEDURE.  VERBATIM: ON TWO SEPARATE OCCASIONS CATHETER BROKE OFF ITS BASE WHILE REMOVING CATHETER FROM PATIENT AS WE NORMALLY REMOVE WHEN COMPLETING PROCEDURE. THE FIRST OCCASION I WITNESSES THIS HAPPEN WHILE THE RADIOLOGIST WAS PERFORMING THE PROCEDURE. THE SECOND INCIDENT THE CATHETER BROKE OFF WHILE I WAS COMPLETING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11143441 ↗