MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPISPIN LOCK -CATHETER-; ANAESTHESIA CONDUCTION KIT, SPINAL-EPIDURAL, CONTINUOUS

Model Number	0021351-30
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical produkte gmbh.Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
Irn#: (b)(4).Initial reporter´s narrative: catheter sheared off.
Additional Manufacturer Narrative
Event took place in germany and has been reported through german distribution subsidiary (b)(4).As the risk of shearing-off a catheter is commonly known and referred to in the instructions for use and as this risk is assessed in the risk management file as well as in the clinical data evaluated this file is considered as closed.
Event or Problem Description
Irn# (b)(6).Initial reporter´s narrative: catheter sheared off.

• Brand Name: EPISPIN LOCK -CATHETER-
• Common Device Name: ANAESTHESIA CONDUCTION KIT, SPINAL-EPIDURAL, CONTINUOUS
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9143779
• Report Number: 9611612-2019-00028
• Device Sequence Number: 11472323
• Product Code: CAZ
• UDI-Device Identifier: 14048223009410
• UDI-Public: 14048223009410
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: 0021351-30
• Device Catalogue Number: 0021351-30
• Device Lot Number: 1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other