MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for SURESTEP? FOLEY TRAY SYSTEM BARDEX? I.C. COMPLETE CARE FOLEY CATHETER A319416AM manufactured by C. R. Bard, Inc..
[185706309]
Bd/bard has informed our healthcare system that they will be on an extensive, long term back order through the end of the summer on all skus of the foley trays- all fr. Sizes, silicone, and the bardex ic. They claim this is due to the eto sterilization plant in (b)(6). This is the most used catheter in the country and our healthcare system is now forced to switch to another company in order to secure inventory of foley trays and provide care to our patients who need this important device. Manufacturer response for bd/bard temp sensing foley sure step trays, bard/bd sure step foley trays (per site reporter). Bd/ bard rep aware.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902901 |
| MDR Report Key | 9902901 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-20 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| 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 BARDEX? I.C. COMPLETE CARE FOLEY CATHETER |
| Generic Name | CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES |
| Product Code | MJC |
| Date Received | 2020-03-31 |
| Model Number | A319416AM |
| Catalog Number | A319416AM |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Manufacturer Address | 1211 MARY MAGNAN BLVD MADISON GA 30650 US 30650 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |