MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG SET; ANALGESIA PROVIDING CATHETER, INFILTRATION

Model Number 001158-10A

Device Problems Fracture (1260); Material Rupture (1546)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).Catheter ruptured during removal.Piece of 20 cm remained in patient.Had to be surgically removed.

Event Description

Irn# (b)(4).Catheter ruptured during removal.Piece of 20cm remained in patient.Had to be surgically removed.

Manufacturer Narrative

Event took place in the uk and has been reported through british distribution subsidiary pajunk medical ltd.Based on risk assessment and clinical assessment this file is considered as closed.Attachment: [complaint report for 414-18.Pdf].

• Brand Name: INFILTRALONG SET
• Type of Device: ANALGESIA PROVIDING CATHETER, INFILTRATION
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 8099226
• MDR Text Key: 128588861
• Report Number: 9611612-2018-00042
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 14048223016036
• UDI-Public: 14048223016036
• Combination Product (y/n): N
• PMA/PMN Number: K080675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: 001158-10A
• Device Catalogue Number: 001158-10A
• Device Lot Number: 1259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 11/23/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other