MAUDE Adverse Event Report: SMITHS MEDICAL ASP INC. WHITACRE 25; WHITACRE 25G

Lot Number 3036604

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2016

Event Type  malfunction  

Event Description

A1368-25 spinal 25g whitacre by smiths medical contains bupivacaine 7.5mg/ml with dextrose 82.5mg/ml - 2ml that operating room physicians believe is suboptimal.Lot: 3036604, use by: (b)(6) 2018, mfg date: 08/2015.Requested medication be available from pharmacy to supplement kit.Operating room contacted smiths medical to report this information.

• Brand Name: WHITACRE 25
• Type of Device: WHITACRE 25G
• Manufacturer (Section D): SMITHS MEDICAL ASP INC.
• MDR Report Key: 5513423
• MDR Text Key: 40858356
• Report Number: MW5060961
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2018
• Device Lot Number: 3036604
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1