MAUDE Adverse Event Report: TELEFLEX MEDICAL FLEXBLOCK KIT:ECHO CATH, 17GX8CM STM NDL; ANESTHESIA CONDUCTION KIT

Catalog Number	FB-19608-K
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "patient for ankle surgery and peripheral nerve block/catheter in preop.When attempting to release the catheter from the stylet, it would not release.Anesthesiologist had to manually cut and pull sheath away from the catheter, and when sheath was removed, it was bent on the end." there was no harm to the patient.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the nerve block catheter with no relevant findings.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.
Event or Problem Description
It was reported that: "patient for ankle surgery and peripheral nerve block/catheter in preop.When attempting to release the catheter from the stylet, it would not release.Anesthesiologist had to manually cut and pull sheath away from the catheter, and when sheath was removed, it was bent on the end." there was no harm to the patient.

• Brand Name: FLEXBLOCK KIT:ECHO CATH, 17GX8CM STM NDL
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21065766
• Report Number: 9680794-2025-00006
• Device Sequence Number: 11615409
• Product Code: CAZ
• UDI-Device Identifier: 40801902069168
• UDI-Public: (01)40801902069168(11)240502(17)260430(10)33F24C0257(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K122027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 04/30/2026
• Device Catalogue Number: FB-19608-K
• Device Lot Number: 33F24C0257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown