MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) SUREBLOCK SPINAL ANALGESIA KIT WITH 0.75% BUPIVACAINE AND 8.25% DEXTROSE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number ASA-24090-SB

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/07/2022

Event Type  malfunction  

Event Description

Spinal bupivacaine product that is part of a spinal anesthesia kit reportedly did not provide analgesia.Fda safety report id# (b)(4).

• Brand Name: SUREBLOCK SPINAL ANALGESIA KIT WITH 0.75% BUPIVACAINE AND 8.25% DEXTROSE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED); morrisville NC 27560
• MDR Report Key: 15815866
• MDR Text Key: 303996763
• Report Number: MW5113334
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/10/2022

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: 04/30/2024
• Device Model Number: ASA-24090-SB
• Device Lot Number: 13F22E0212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose