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

Model Number 001158-30C

Device Problem Material Separation (1562)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in the u.S.And has been reported by (b)(6) customer teleflex through (b)(4).Has been reported late by (b)(6) customer.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)(6).User´s narrative: catheter separated from connection hub after placement in patient.Discovered in icu.Catheter had been inserted in the left chest.It was removed and was not replaced.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).User's narrative: catheter separated from connection hub after placement in patient.Discovered in icu.Catheter had been inserted in the left chest.It was removed and was not replaced.

• Brand Name: INFILTRALONG
• Type of Device: PERIPHERAL NERVE BLOCK INFILTRATION 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: 5905931
• MDR Text Key: 54062412
• Report Number: 9611612-2016-00119
• Device Sequence Number: 1
• Product Code: BSO
• 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: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/01/2020
• Device Model Number: 001158-30C
• Device Catalogue Number: 001158-30C
• Device Lot Number: 1129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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