MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE E-CATH; KIT, PERIPHERAL ANAESTHESIA CONDUCTION, PRODUCT CODE: BSO

Model Number	251285-40E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initially received through fda, uf/importer report # (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 or Problem Description
(b)(4).Event title: tubing missing from package that connects to needle.Describe the event or problem: sterile catheter kits missing the tubing that connects on the luer lock part on the needle (not the tubing attached to the inner catheter.) what problem did the user have (check all that apply): device malfunction - that is, the device did not do what it was supposed to do;.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation report update this file is considered as closed.
Event or Problem Description
Irn# (b)(4).Medsun user report number: (b)(4).Event title: tubing missing from package that connects to needle -------------------------------------- describe the event or problem: sterile catheter kits missing the tubing that connects on the luer lock part on the needle (not the tubing attached to the inner catheter.) -------------------------------------- what problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do;.

• Brand Name: E-CATH
• Common Device Name: KIT, PERIPHERAL ANAESTHESIA CONDUCTION, PRODUCT CODE: BSO
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8334597
• Report Number: 9611612-2019-00003
• Device Sequence Number: 11009499
• Product Code: BSO
• UDI-Device Identifier: 14048223037345
• UDI-Public: 14048223037345
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K152952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: 251285-40E
• Device Catalogue Number: 251285-40E
• Device Lot Number: 1277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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