MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPIDURAL FILTER EPILONG KIT; KIT FOR CONTINUOUS EPIDURAL ANAESTHESIA

Model Number 001151-37X

Device Problems Crack (1135); Fluid/Blood Leak (1250); Fracture (1260); Leak/Splash (1354)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4).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).Summarizing tentative translation from initial reporter's narrative: filter start leaking after 1-2 days analgesia.At least 10 filters involved.

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4).Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).Summarizing tentative translation from initial reporter´s narrative: filter start leaking after 1-2 days analgesia.At least 10 filters involved.

• Brand Name: EPIDURAL FILTER EPILONG KIT
• Type of Device: KIT FOR CONTINUOUS EPIDURAL ANAESTHESIA
• 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: 5979100
• MDR Text Key: 55686865
• Report Number: 9611612-2016-00129
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060311
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 001151-37X
• Device Catalogue Number: 001151-37X
• Device Lot Number: 1144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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