MAUDE Adverse Event Report: TELEFLEX MEDICAL/ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK KIT; ANESTHESIA CONDUCTION KIT

Catalog Number FB-19608

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

Flexblock continuous peripheral nerve kit lot: 33f23j0428 states there is a statlock catheter stabilization device with 6 inch tubing included in the kit.There was no stat lock in the kit.The kit was not used on a patient and all kits were removed from the shelves to prevent further utilization on the floors.

• Brand Name: ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL/ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 18930039
• MDR Text Key: 338156234
• Report Number: MW5152950
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FB-19608
• Device Lot Number: 33F23J0428
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other