MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG; 868.5120 ANESTHESIA CONDUCTION CATHETER

Model Number 001158-30C

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

(b)(4).Event took place in (b)(6) and has not been reported to (b)(6).Summary of user's narrative from initial report: "catheter perforated 300mm and not 220mm.An additional intervention was not necessary, the pt is doing well.".

Manufacturer Narrative

No specific corrective action due to mitigative prevention of hazards is assigned to this report.A review of the relevant device history records and the raw material history files did neither indicate recorded qual problems nor rejections related to this incident.If any further info is becoming available, mfr immediately will inform fda.If no further info is becoming available, mfr considers this file as closed.After evaluation of the data, the failure was caused at the mfg of the catheter.At the end control, the failure was not detected and the faulty products thus not sorted out.This is not a systematic product failure, the failure is limited to individual items.

• Brand Name: INFILTRALONG
• Type of Device: 868.5120 ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-strasse 1; geisingen, baden-wurttemberg 7818 7; GM 78187
• Manufacturer Contact: christian quass, dir reg affairs ; karl-hall-str 1; 7049291586
• MDR Report Key: 4016113
• MDR Text Key: 4879682
• Report Number: 9611612-2014-00012
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K080675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2013
• Device Model Number: 001158-30C
• Device Lot Number: 1042
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2014
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other