MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG; PERIPHERAL NERVE BLOCK CATHETER

Model Number 001158-10A

Device Problems Failure To Adhere Or Bond (1031); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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).Date of event is unknown/ has not been reported.Summarizing tentative translation from initial reporter's narrative: catheter split apart during use.

Event Description

(b)(4).Date of event is still unknown and has not been reported.Summarizing tentative translation from initial reporter´s narrative: catheter split apart during use.

• Brand Name: INFILTRALONG
• Type of Device: PERIPHERAL NERVE BLOCK CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 6059535
• MDR Text Key: 58455092
• Report Number: 9611612-2016-00145
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 04048223016039
• UDI-Public: 04048223016039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

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: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 001158-10A
• Device Catalogue Number: 001158-10A
• Device Lot Number: 1145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other