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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVID MEDICAL C-SECTION PACK; OBSTETRICAL KIT

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AVID MEDICAL C-SECTION PACK; OBSTETRICAL KIT Back to Search Results
Catalog Number HSAM00405
Device Problems Moisture Damage (1405); Device Packaging Compromised (2916)
Patient Problem No Information (3190)
Event Date 02/14/2017
Event Type  malfunction  
Event Description
A cesarean pack was opened and there was moisture found to be in the blood tube, and the towels and lap sponges were damp.Due to wetness/moisture present, the sterility of the pack was compromised.All packs from lot number were pulled and hospital supply company was notified.An avid medical complaint form was completed.
 
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Brand Name
C-SECTION PACK
Type of Device
OBSTETRICAL KIT
Manufacturer (Section D)
AVID MEDICAL
MDR Report Key6399106
MDR Text Key69893988
Report NumberMW5068407
Device Sequence Number1
Product Code OKV
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/09/2017
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 Catalogue NumberHSAM00405
Device Lot Number1218060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/09/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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