MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER

Catalog Number	UI-05502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "twice in the last month, the catheter from this kit has broken off when being pulled out/discontinued.With the most recent occurrence last thursday, the catheter and the internal wire broke off.The patients were consulted with the neuro surgery team and had to go back to the operating room to have the remainder of the catheter removed." associated complaints: 9680794-2024-00524, 9680794-2024-00523.
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that: "twice in the last month, the catheter from this kit has broken off when being pulled out/discontinued.With the most recent occurrence last thursday, the catheter and the internal wire broke off.The patients were consulted with the neuro surgery team and had to go back to the operating room to have the remainder of the catheter removed." associated complaints: 9680794-2024-00524, 9680794-2024-00523 and 9680794-2024-00525.
Additional Manufacturer Narrative
(b)(4)."new information received indicates that this was not a reportable event, thus, the initial mdr submitted on 06/04/2024 should be re tracted.".

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19456788
• Report Number: 9680794-2024-00525
• Device Sequence Number: 7925685
• Product Code: BSO
• UDI-Device Identifier: 00801902014160
• UDI-Public: 00801902014160
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: UI-05502
• Device Lot Number: 33F23J0523
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown