MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-07 for PRESOURCE CUSTOM PACK SAN35CCBHM manufactured by Cardinal Health.
[352609]
While performing a cardiac catheterization, physician and scrub tech found a lint-like, blackish, grayish, greasy material that resembled mold in a pile of 4x4 sponges that came from a sterile femoral pack tray. Physician changed gloves, pt was given kefzol 1 gm ivpb for prophylaxis. Physician was initially planning to use sealing device on the arteriotomy site so pt doesn't have to lie flat for so long, due to pre-existing back problems. Instead, pt was transferred to the floor with femoral sheath in place, which warrants a longer bedrest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 548289 |
| MDR Report Key | 548289 |
| Date Received | 2004-10-07 |
| Date of Report | 2004-10-05 |
| Date of Event | 2004-09-29 |
| Date Facility Aware | 2004-09-29 |
| Report Date | 2004-10-05 |
| Date Added to Maude | 2004-10-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESOURCE CUSTOM PACK |
| Generic Name | STERILE FEMORAL TRAY PK |
| Product Code | MCY |
| Date Received | 2004-10-07 |
| Model Number | NA |
| Catalog Number | SAN35CCBHM |
| Lot Number | ORDER 116356 |
| ID Number | STOCK CS-214-FR |
| Device Expiration Date | 2006-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 537755 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-07 |