MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-06 for ALL SILICONE CATHETER UNK manufactured by C.r. Bard, Inc. (covington) -1018233.
[185227759]
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
[185227760]
It was reported that the patient came into facility and a foley was placed in the er. Once the patient was placed on the floor it was noted that the patient was excessively wet. After the removal of the foley, the foley was found to be cracked near they port and was discarded at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01608 |
| MDR Report Key | 9800604 |
| Report Source | CONSUMER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-04-02 |
| Date Mfgr Received | 2020-03-31 |
| Date Added to Maude | 2020-03-06 |
| 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 | ALL SILICONE CATHETER |
| Generic Name | SILICONE |
| Product Code | EZL |
| Date Received | 2020-03-06 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-06 |