MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 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).
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 and 9680794-2025-00403.
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 and 9680794-2025-00403.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The potency of bupivacaine meets the requirements as per the product quality specifications.A device history record review could not be performed as no lot number was provided by the customer.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.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22000628
• Report Number: 9680794-2025-00402
• Device Sequence Number: 9125682
• 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,Followup
• 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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; NOT REPORTED
• Patient Sex: Unknown