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

Model Number 001157-01Z

Device Problems Break (1069); Labelling, Instructions for Use or Training Problem (1318); Improper or Incorrect Procedure or Method (2017); Human Factors Issue (2948); Device Handling Problem (3265)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has not been reported to german health authorities.This case in particular is considered as closed.Individual cases were reported earlier but had different root causes not affecting the patient or prior to use.Since there are additional complaints/ there is additional feedback this has been identified to be reportable to fda.Therefore a summarizing analysis has been conducted.The incident/ the device group is under monitoring and continuing trend analysis.Device not returned.

Event Description

Internal report-number: (b)(4).User's narrative (tentative summarizing translation from (b)(6)): all three catheters parted each from the kink bend protection to implantation and wound closure out.Catheter had to be taken in the operating room.The patient was not harmed.Client: "ok, the last two, unfortunately, are already in the trash.((b)(6) 2016)." today at last tep unfortunately again ".Goods was discarded.

• Brand Name: INFILTRALONG CATHETER
• Type of Device: WOUND INFUSION 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: 5503642
• MDR Text Key: 40408099
• Report Number: 9611612-2016-00030
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 001157-01Z
• Device Catalogue Number: 001157-01Z
• Device Lot Number: 1135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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