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

Model Number 131151-603

Device Problems Failure To Adhere Or Bond (1031); Break (1069); Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2016

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).Initial reporters narrative: patient was in the icu and the catheter broke off".The alleged defect occurred during use.There was no patient injury or consequence.The patient's condition is reported as "fine".

Manufacturer Narrative

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

Event Description

(b)(4).Initial reporters narrative: patient was in the icu and the catheter broke off".The alleged defect occurred during use.There was no patient injury or consequence.The patient's condition is reported as "fine".

• Brand Name: INFILTRALONG DUO
• Type of Device: WOUND 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: 6197508
• MDR Text Key: 63488287
• Report Number: 9611612-2016-00160
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 04048223027813
• UDI-Public: 04048223027813
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/01/2021
• Device Model Number: 131151-603
• Device Catalogue Number: 131151-603
• Device Lot Number: 1156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/01/2016
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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