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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASP INC. WHITACRE 25 WHITACRE 25G Back to Search Results
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.
 
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Brand NameWHITACRE 25
Type of DeviceWHITACRE 25G
Manufacturer (Section D)
SMITHS MEDICAL ASP INC.
MDR Report Key5513423
MDR Text Key40858356
Report NumberMW5060961
Device Sequence Number1
Product Code CAZ
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Lot Number3036604
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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