MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-21 for BARDEX? LUBRI-SIL? I.C. ALL-SILICONE FOLEY CATHETER 1758SI16 manufactured by C.r. Bard, Inc. (covington) -1018233.
[186417876]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186417877]
It was reported that when the doctor went to remove the catheter that had been inflated with the prefilled 10 cc syringe, they noted that it "didn't seem right" while they were deflating the balloon. The catheter then fell out and it was noticed that the balloon had split. It was a clean slice, not a jagged slice, so it was almost like it had split, not blown. They did not lose any pieces, as it came out in one piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01998 |
| MDR Report Key | 9863567 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-21 |
| Date of Report | 2020-03-21 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-21 |
| 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? LUBRI-SIL? I.C. ALL-SILICONE FOLEY CATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | EZL |
| Date Received | 2020-03-21 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 1758SI16 |
| Catalog Number | 1758SI16 |
| Lot Number | NGDW0019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-21 |