MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPINAL ANESTHESIA KIT; NEEDLE, CONDUCTION, ANESTHETI

Catalog Number	ASA-25090-SB
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "bupivacaine included with spinal tray was ineffective.6 patients had to be transitioned to general anesthesia due to patients moving and responding during procedure.Pt's were undergoing total hip/total knee replacements." associated complaints: 9680794-2024-01025, 9680794-2024-01023, 9680794-2024-01022 and 9680794-2024-01021, 968 0794-2024-01012.
Event or Problem Description
It was reported that: "bupivacaine included with spinal tray was ineffective.6 patients had to be transitioned to general anesthesia due to patients moving and responding during procedure.Pt's were undergoing total hip/total knee replacements." associated complaints: 9680794-2024-01025, 9680794-2024-01023, 9680794-2024-01022, and 9680794-2024-01021, 968 0794-2024-01012.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The potency of bupivacaine is within the specified requirements.A device history record review was performed on the bupivacaine ampule with no evidence to suggest a manufacturing related cause.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 on complaints of this nature.

• Brand Name: ARROW SPINAL ANESTHESIA KIT
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETI
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20381981
• Report Number: 9680794-2024-01024
• Device Sequence Number: 12764446
• Product Code: BSP
• UDI-Device Identifier: 50801902074190
• UDI-Public: (01)50801902074190(11)240423(17)260228(10)33F24C0030(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K911260
• 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): 09/17/2024

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: 02/28/2026
• Device Catalogue Number: ASA-25090-SB
• Device Lot Number: 33F24C0030
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2024
• 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