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

Model Number 001157-20B

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).Follow up will be sent to agency once investigations are finished.

Event Description

(b)(4).Tentative summarizing translation from user's narrative: after providing infiltration analgesia and upon removal, the catheter got loosened from the hub.Happened 2 times.

Manufacturer Narrative

In case no further information becomes available we consider this file as closed.

Event Description

(b)(4).Tentative summarizing translation from user's narrative: after providing infiltration analgesia and upon removal the catheter got loosened from the hub.Happened 2 times.

• Brand Name: INFILTRALONG CATHETER
• Type of Device: CATHETER FOR WOUND INFUSION
• 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: 5549724
• MDR Text Key: 41942015
• Report Number: 9611612-2016-00036
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 001157-20B
• Device Catalogue Number: 001157-20B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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