DEROYAL VENOUS PACK BOWL 89-8672.02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-09 for DEROYAL VENOUS PACK BOWL 89-8672.02 manufactured by Deroyal.

Event Text Entries

[64525078] Opened sterile venous pack lot #43483479 to prep for pt procedure. Noted a small back speck in sterile bowl. No saline or other products were added to the bowl. Black speck is loose and moves in bowl. The entire drape was folded, and closed and entire tray not used. This was noted before any procedure and no products from this tray came in contact with the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5067146
MDR Report Key6237685
Date Received2017-01-09
Date of Report2017-01-09
Date of Event2017-01-06
Date Added to Maude2017-01-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDEROYAL VENOUS PACK BOWL
Generic NameVENOUS PACK BOWL 16 OZ
Product CodePEZ
Date Received2017-01-09
Returned To Mfg2017-01-09
Model Number89-8672.02
Lot Number43483479
Device Expiration Date2019-08-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL
Manufacturer AddressPOWELL TN 37849 US 37849


Patients

Patient NumberTreatmentOutcomeDate
10 2017-01-09

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