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

Model Number 0331152-51

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problems Awareness during Anaesthesia (1707); No Code Available (3191)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).At this time neither detailed information nor the device is available.As soon as more data is accessible a follow up report will be sent in.Not yet returned.

Event Description

(b)(4).The sealing inside the lor-syringe got loosened; unable to identify epidural space via lor-technique.

Manufacturer Narrative

Event took place in (b)(6).If no further information becomes available, this particular file is considered as closed.

Event Description

(b)(4).The sealing inside the lor-syringe got loosened; unable to identify epidural space via lor-technique.

• Brand Name: EPILONG
• Type of Device: KIT FOR 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: 5450196
• MDR Text Key: 39198036
• Report Number: 9611612-2016-00021
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: 0331152-51
• Device Catalogue Number: 0331152-51
• Device Lot Number: 1107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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