MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC SPINAL ANESTHESIA KIT: 25 GA X 9 CM; NEEDLE, CONDUCTION, ANESTHETI

Catalog Number	ASK-24090-SPH
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer reported the medication was ineffective.The customer returned twenty sealed kits.The reported complaint of the medication being ineffective could not be confirmed.The potency of the bupivacaine met specifications according to the manufacture's coa.A device history record review was performed on the bupivacaine ampule with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined.No further action is required at this time.
Event or Problem Description
It was reported that: "last week we had two different anesthesia providers have issues w/ spinals not working and they believe it was the drugs in the kit.' i spoke with our chief of anesthesia, and he confirmed that the bupivacaine had no effect on the patients, and the kits themselves were fine." there was no reported patient harm or consequence.They were reproted as fine psot the procedure.Associated complaints: 9680794-2025-00402.

• Brand Name: SPINAL ANESTHESIA KIT: 25 GA X 9 CM
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETI
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22001000
• Report Number: 9680794-2025-00403
• Device Sequence Number: 15237787
• Product Code: BSP
• UDI-Device Identifier: 10801902064070
• UDI-Public: (01)10801902064070(11)240612(17)260228(10)33F24C0239(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/16/2025

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: ASK-24090-SPH
• Device Lot Number: 33F24C0239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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
• Patient Sex: Unknown