MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FLEXBLOCK SET:ECHO CATH, 17GX8CM STM NDL; ANESTHESIA CONDUCTION KIT

Catalog Number	FB-19608-SST
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "patient was sent home with instructions from the hospital to remove the catheter when the elastomeric pump was empty.The patients partner was unable to remove it, and so cut the catheter - a surgical intervention had to be performed with an the incision made on the patient's collarbone and chest to remove the catheter -installed subclavian.".
Additional Manufacturer Narrative
(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 evidence to indicate a manufacturing related issue.The customer did provide photos that appear to show two lidstock.However, the potential cause of this complaint could not be determined based upon the information provided and without a sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "patient was sent home with instructions from the hospital to remove the catheter when the elastomeric pump was empty.The patients partner was unable to remove it, and so cut the catheter - a surgical intervention had to be performed with an the incision made on the patient's collarbone and chest to remove the catheter -installed subclavian.".

• Brand Name: ARROW FLEXBLOCK SET:ECHO CATH, 17GX8CM STM NDL
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24276481
• Report Number: 3006425876-2026-00110
• Device Sequence Number: 9962989
• Product Code: CAZ
• UDI-Device Identifier: 00801902069184
• UDI-Public: (01)00801902069184(11)250616(17)270531(10)71F25F0575(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 Catalogue Number: FB-19608-SST
• Device Lot Number: UNKNOWN
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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