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

Catalog Number ASA-24090-SB

Device Problem Lack of Effect (4065)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

It was reported that "anesthesia provider placed the spinal and noted the placement was 'textbook' and when the bupivacaine was infused it had no affect to anesthetize the patient.The provider then had to utilize and epidural to complete the procedure".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

Qn# (b)(4).The reported complaint of the medication being ineffective could not be confirmed upon evaluation of the returned seal kit.The potency of the bupivacaine met specifications according to the manufacture's certificate of analysis.A device history record review was performed on the bupivacaine ampule with no evidence to suggest a manufacturing related cause.Therefore, the potential root cause of this complaint could not be determined.No further action was required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "anesthesia provider placed the spinal and noted the placement was 'textbook' and when the bupivacaine was infused it had no affect to anesthetize the patient.The provider then had to utilize and epidural to complete the procedure".No patient harm or injury.The patient status is reported as "fine.".

• Brand Name: SPINAL ANESTHESIA KIT
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC
• 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 27560
• MDR Report Key: 17673542
• MDR Text Key: 322542176
• Report Number: 9680794-2023-00639
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 40801902074179
• UDI-Public: 40801902074179
• 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: 08/16/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: ASA-24090-SB
• Device Lot Number: 13F21L0943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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