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

Catalog Number ASK-24090-SPH

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Event 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".

Manufacturer Narrative

(b)(4).

Event 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".

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
• Type of Device: 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
• MDR Text Key: 328381989
• Report Number: 9680794-2023-00926
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 10801902064070
• UDI-Public: 10801902064070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female