MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-14 for SURESTEP FOLEY TRAY SYSTEM A303316A manufactured by Bard Medical.
[33358167]
Patient Sequence No: 1, Text Type: N, H10
[33358168]
Opened 4 separate foley kits and all were missing the wipes from the baggy for pre-cleaning.
Patient Sequence No: 1, Text Type: D, B5
[110488252]
Patient Sequence No: 1, Text Type: N, H10
[110488253]
Opened 4 separate foley kits and all were missing the wipes from the baggy for pre-cleaning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5292437 |
| MDR Report Key | 5292437 |
| Date Received | 2015-12-14 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-12-08 |
| Report Date | 2015-12-09 |
| Date Reported to FDA | 2015-12-09 |
| Date Reported to Mfgr | 2015-12-09 |
| Date Added to Maude | 2015-12-14 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESTEP FOLEY TRAY SYSTEM |
| Generic Name | KIT, FOLEY, CATHETER |
| Product Code | NWR |
| Date Received | 2015-12-14 |
| Model Number | A303316A |
| Catalog Number | A303316A |
| Lot Number | NGZJ0273 |
| ID Number | PK7635559, $$900001518031NGZJ |
| Device Expiration Date | 2018-01-31 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD MEDICAL |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-14 |