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	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the drug didn't make or keep the patient numb".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the drug didn't make or keep the patient numb".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).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.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18151023
• Report Number: 9680794-2023-00926
• Device Sequence Number: 17829495
• Product Code: BSP
• UDI-Device Identifier: 10801902064070
• UDI-Public: 10801902064070
• 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): 11/08/2023

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: 05/31/2025
• Device Catalogue Number: ASK-24090-SPH
• Device Lot Number: 33F23F0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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
• Patient Sex: Female