MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPISPIN LOCK; CONTINUOUS COMBINED SPINAL EPIDURAL NERVE BLOCK KIT

Model Number 0021351-18

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2016

Event Type  Injury  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(6) 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 in to the agency.

Event Description

(b)(4).Summarizing tentative translation from initial reporter´s narrative:upon removal of catheter after 2 days (48 hours) catheter ruptured/ broke of.Fragment was left with patient.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).Summarizing tentative translation from initial reporter´s narrative:upon removal of catheter after 2 days (48 hours) catheter ruptured/ broke of.Fragment was left with patient.Patient has been informed.

• Brand Name: EPISPIN LOCK
• Type of Device: CONTINUOUS COMBINED SPINAL EPIDURAL NERVE BLOCK 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: 6197509
• MDR Text Key: 63067590
• Report Number: 9611612-2016-00162
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 04048223009390
• UDI-Public: 04048223009390
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/01/2020
• Device Model Number: 0021351-18
• Device Catalogue Number: 0021351-18
• Device Lot Number: 1140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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; Required Intervention