MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-24 for BARDEX? ALL-SILICONE FOLEY CATHETER 165814 manufactured by C.r. Bard, Inc. (covington) -1018233.
[188339116]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[188339117]
It was reported that it was difficult to deflate the balloon of the catheter. Reportedly, only 5ml of water was coming out causing trauma and bleeding to the patient. Five patients were admitted to hospital. It is unknown at this time if the patient required medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02067 |
| MDR Report Key | 9874110 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARDEX? ALL-SILICONE FOLEY CATHETER |
| Generic Name | FOLEY CATHETER (SILICONE) |
| Product Code | GBM |
| Date Received | 2020-03-24 |
| Catalog Number | 165814 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-24 |