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

Model Number 251285-40E

Device Problem Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  malfunction  

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 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;.

Manufacturer Narrative

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

Event 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
• Type of Device: 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
• MDR Text Key: 135997557
• Report Number: 9611612-2019-00003
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 14048223037345
• UDI-Public: 14048223037345
• Combination Product (y/n): N
• PMA/PMN Number: K152952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other