MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; ANESTHESIA CONDUCTION KIT

Model Number AK-05000

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

The catheter was found to have a kink and was not usable when pulled out of the packaging.

• Brand Name: ARROW
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13860401
• MDR Text Key: 287673208
• Report Number: 13860401
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AK-05000
• Device Lot Number: 13F22A0111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Male
• Patient Race: White