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

Model Number	001157-10A
Medical Device Problem Codes	Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PAIN THERAPY CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8639207
• Report Number: 9611612-2019-00013
• Device Sequence Number: 1815835
• Product Code: BSO
• UDI-Device Identifier: 14048223016036
• UDI-Public: 14048223016036
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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