MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG CATHETER; PAIN THERAPY CATHETER

Model Number 001157-10A

Device Problems Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Incident took place in (b)(6) and has been reported by local distributor dongbang healthcare.Currently the data provided is very poor.As soon as more details become available further reports will be filed with the agency.

Event Description

Irn# (b)(4).Initial reporter´s narrative: in attempt to remove 001157-10a catheter after 2 days of use on a c-section patient, the doctor noticed that part of the catheter broke off.The broken portion of catheter is scheduled to be removed.

Event Description

Irn# 627_146-19.Initial reporter´s narrative: in attempt to remove 001157-10a catheter after 2 days of use on a c-section patient, the doctor noticed that part of the catheter broke off.The broken portion of catheter is scheduled to be removed.

Manufacturer Narrative

Incident took place in south korea and has been reported by local distributor dongbang healthcare.Based on risk assessment and clinical evaluation this case is considered as closed.- attachment: [complaint report for 146-19.Pdf].

• Brand Name: INFILTRALONG CATHETER
• Type of Device: PAIN THERAPY CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8639207
• MDR Text Key: 146492920
• Report Number: 9611612-2019-00013
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

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: 09/24/2023
• Device Model Number: 001157-10A
• Device Catalogue Number: 001158-10A
• Device Lot Number: 1270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other