MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-21 for BARDEX? LUBRI-SIL? ALL-SILICONE FOLEY CATHETER 175812 manufactured by C.r. Bard, Inc. (covington) -1018233.
[186410604]
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
[186410605]
It was reported that when the patient was going to bed, they had stomach pain and then the catheter fell out. The catheter was inspected, it was noted that the balloon had burst and there was a split in the catheter that could be realigned with no issues. There were no missing pieces noted. An additional member of the staff inspected the balloon and agreed with the previous assessment. A new catheter with a different lot number reinserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01996 |
| MDR Report Key | 9863562 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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? ALL-SILICONE FOLEY CATHETER |
| Generic Name | LUBRISIL MALE CATHETER |
| Product Code | EZL |
| Date Received | 2020-03-21 |
| Catalog Number | 175812 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |