MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG 500; PERIPHERAL ANAESTHEIA/ ANALGESIA CATHETER

Model Number	001158-20B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
(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 its entirety.Catheter breakage.Part remained in patient.1st.Cath.Detected imediately.2st.Chat.Detected 6 month later.

• Brand Name: INFILTRALONG 500
• Common Device Name: PERIPHERAL ANAESTHEIA/ ANALGESIA CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10315690
• Report Number: 9611612-2020-00006
• Device Sequence Number: 3294225
• Product Code: BSO
• UDI-Device Identifier: 14048223016043
• UDI-Public: 14048223016043
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 001158-20B
• Device Catalogue Number: 001158-20B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other