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

Model Number 001151-637

Device Problems Nonstandard Device (1420); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical (b)(4).Based on risk assessment and clinical evaluation file is considered as closed.As soon as further significant 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: unable to advance catheter over the ramp in the tip of the spinal needle.

• Brand Name: KIT FOR EPIDURAL ANAESTHESIA
• Type of Device: CONTINUOUS 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; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7057553
• MDR Text Key: 93572515
• Report Number: 9611612-2017-00014
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/01/2022
• Device Model Number: 001151-637
• Device Catalogue Number: 001151-637
• Device Lot Number: 26217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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