MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG; WOUND INFILTRATION CATHETER

Model Number	001158-20B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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).Initial user´s narrative: catheter broke upon removal.The wound catheter snapped on removal, leaving a length of catheter inside the patient.Required a general anaesthetic to remove the remaining catheter.
Additional Manufacturer Narrative
Event took place in the (b)(6) and has been reported through (b)(4).Based on risk management this file is considered as closed.(b)(4).
Event or Problem Description
(b)(4).Initial user´s narrative: catheter broke upon removal.The wound catheter snapped on removal, leaving a length of catheter inside the patient.Required a general anaesthetic to remove the remaining catheter.

• Brand Name: INFILTRALONG
• Common Device Name: WOUND INFILTRATION CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7284983
• Report Number: 9611612-2018-00015
• Device Sequence Number: 19427840
• Product Code: BSO
• UDI-Device Identifier: 14048223016043
• UDI-Public: 14048223016043
• 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: distributor,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: Physician
• Device Expiration Date: 10/16/2022
• Device Model Number: 001158-20B
• Device Catalogue Number: 001158-20B
• Device Lot Number: 1225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2018
• Supplement Date Received by Manufacturer: 02/11/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/26/2018
• 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; Required Intervention