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.
[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
| Report Number | 9753470 |
| MDR Report Key | 9753470 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-08 |
| Report Date | 2020-01-10 |
| Date Reported to FDA | 2020-01-10 |
| Date Reported to Mfgr | 2020-02-26 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL HEALTH |
| Generic Name | ORTHOPEDIC TRAY-KIT |
| Product Code | OJH |
| Date Received | 2020-02-26 |
| Model Number | SOP56TK80H |
| Catalog Number | SOP56TK80H |
| Lot Number | 340859 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |