CARDINAL HEALTH SOP56TK80H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for CARDINAL HEALTH SOP56TK80H manufactured by Cardinal Health 200, Llc.

Event Text Entries

[180867179] Dull scalpel blades in the ortho tray-kit, unable to even cut through ioban skin drape on initial surgical incision. The blades within the pack are bard-parker rib-back, lot #0200156. All 6 blades from this pack were dull. Another pack was opened (same catalog # and lot#) that had at least 2 dull blades in the pack. Same lot # on all blades.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9753470
MDR Report Key9753470
Date Received2020-02-26
Date of Report2020-01-10
Date of Event2020-01-08
Report Date2020-01-10
Date Reported to FDA2020-01-10
Date Reported to Mfgr2020-02-26
Date Added to Maude2020-02-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 Report3

Device Details

Brand NameCARDINAL HEALTH
Generic NameORTHOPEDIC TRAY-KIT
Product CodeOJH
Date Received2020-02-26
Model NumberSOP56TK80H
Catalog NumberSOP56TK80H
Lot Number340859
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

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