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

Model Number	001158-10A
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
(b)(4).Catheter ruptured during removal.Piece of 20 cm remained in patient.Had to be surgically removed.
Event or Problem Description
Irn# (b)(4).Catheter ruptured during removal.Piece of 20cm remained in patient.Had to be surgically removed.
Additional 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
• Common Device Name: 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
• Report Number: 9611612-2018-00042
• Device Sequence Number: 19262642
• Product Code: BSO
• UDI-Device Identifier: 14048223016036
• UDI-Public: 14048223016036
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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