InfiltraLong set consisting of: 001158-20BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14048223016043), received between Feb 21, 2018 and Jul 23, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJul 23, 2020Break; Break

  (B)(4). INITIAL USER¿S NARRATIVE: FOR THE SECOND TIME, A (LONG) FRAGMENT OF KT FROM PERI-CICATRICIAL ANALGESIA REMAINED IN THE WALL OF A PATIENT AND NOBODY NOTICED IT BEFORE LOOKING CAREFULLY AT A SCANNER MOTIVATED BY ANOTHER PROBLEM. IN BOTH CASES, THE KT HAD BEEN PLACED BY ME (DOCTOR) AND REMOVED BY A NURSE ON THE WARD. FOR THE MOST RECENT PATIENT, THE NURSE WHO REMOVED (PART OF) THE KT IS "EXPERIENCED", REPORTED RESISTANCE TO REMOVAL, BUT DID NOT FEEL THAT THE KT WAS SEVERED. FOR THE FIRST PATIENT, I DON'T REMEMBER WHO REMOVED IT, BUT THE PROBLEM WAS NOTICED QUICKLY DURING THE SAME HOSPITALIZATION AND A SMALL RE-INTERVENTION SOLVED THE PROBLEM. FOR THE 2ND PATIENT, WE NOTICE IT 6 MONTHS LATER ON A SCANNER MADE FOR AN EVENTRATION AND WE HAVE TO MAKE THE PATIENT COME BACK FROM FAR AWAY TO REMOVE THE KT, THE EVENTRATION CURE HAVING TO BE MADE IN ANOTHER OPERATION TIME. WHEN LOOKING AT THE KT, ONLY A PRACTITIONER WHO KNOWS ITS STRUCTURE VERY WELL CAN SEE THAT IT IS PARTIALLY REMOVED, AND EVEN IF HE HAS GOOD EYES BECAUSE THE KT IS REALLY THIN AND THE MARKS ON IT ARE NOT EASY TO UNDERSTAND. HOWEVER, IF THE END OF THE KT WAS RED OR GREEN, WE WOULD KNOW WHETHER OR NOT IT WAS REMOVED IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10315690 ↗
• InjuryMar 13, 2019Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  (B)(4). SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: AT THE REMOVE OF THE CATHETER, THE USER TRIED AT 3 TIMES TO REMOVE, THE CATHETER STAYED BLOCKED. AFTER THIS INSISTENCE, THE CATHETER HAS BEEN BROKEN. A NO DETERMINATE LONGUEUR CATHETER IS STAYED INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8415335 ↗
• MalfunctionFeb 21, 2018Fracture; Fracture

  (B)(4). INITIAL USER´S NARRATIVE: CATHETER BROKE UPON REMOVAL. THE WOUND CATHETER SNAPPED ON REMOVAL, LEAVING A LENGTH OF CATHETER INSIDE THE PATIENT. REQUIRED A GENERAL ANAESTHETIC TO REMOVE THE REMAINING CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 7284983 ↗