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

Model Number 0431157-51

Device Problem Retraction Problem (1536)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (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 into the agency.

Event Description

(b)(4).Tentative summarizing translation of initial reporter's narrative: ülacement of catheter for continuous epidural anaesthesia, unable to draw back needle over catheter; stylet got hooked in inner coil.Catheter had to be replaced, procedure re-initialized.

Manufacturer Narrative

With one of the devices involved an individual device failure can be confirmed.The second catheter has been stretched and ruptured due to handling-based complications.Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).Tentative summarizing translation of initial reporter's narrative: placement of catheter for continuous epidural anaesthesia, unable to draw back needle over catheter; stylet got hooked in inner coil.Catheter had to be replaced, procedure re-initialized.Amendment: 2 catheter kits involved.Lot is unknown, packaging has been disposed.

• Brand Name: EPILONG SOFT
• 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: 5596965
• MDR Text Key: 44180645
• Report Number: 9611612-2016-00050
• 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: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 0431157-51
• Device Catalogue Number: 0431157-51
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• 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): Required Intervention