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

Model Number 0431157-51

Device Problems Retraction Problem (1536); Material Too Rigid or Stiff (1544)

Patient Problem No Information (3190)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

Information on incident and device is poor at this time. Follow up will be sent as soon as further details become available. Not yet returned.

Event Description

(b)(4). Users narrative: unable to retract needle over the catheter. Stylet [of catheter] to rigid.

Manufacturer Narrative

Event took place in (b)(6). File is considered as closed.

Event Description

(b)(4). Users narrative: unable to retract needle over the catheter. Stylet [of catheter?] to rigid. Happened with 2 kits.

• Brand Name: EPILONG SOFT
• Type of Device: EPIDURAL ANAESTHESIA KIT
• 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: 5446635
• MDR Text Key: 39100258
• Report Number: 9611612-2016-00016
• 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

• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/01/2020
• Device Model Number: 0431157-51
• Device Catalogue Number: 0431157-51
• Device Lot Number: 1123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/19/2016 Patient Sequence Number: 1