MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-20 for LUBRI-SIL IC COMPLETE CARE FOLEY TRAY #16FR 300416A manufactured by Bard.
[17447296]
(b)(6) female admitted for retropubic mid-urethral sling and cystoscopy. Following completion of the cystoscopy, a bard foley catheter was inserted. The catheter was visually intact at the time of insertion. The rest of the procedure was completed. At the completion of the procedure, the bladder was filled with 150 cc normal saline for voiding trial. The balloon on the foley was aspirated to deflate, but no return was received. When the foley catheter was removed, it was noticed that the full circumference of the balloon was not connected to the catheter. An add'l cystoscopy was performed and the balloon fragment was removed with a grasper forcep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3120510 |
| MDR Report Key | 3120510 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-05-03 |
| Date of Event | 2013-05-01 |
| Date Facility Aware | 2013-05-01 |
| Report Date | 2013-05-03 |
| Date Reported to FDA | 2013-05-06 |
| Date Reported to Mfgr | 2013-05-06 |
| Date Added to Maude | 2013-05-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUBRI-SIL IC COMPLETE CARE FOLEY TRAY #16FR |
| Generic Name | FOLEY CATHETER |
| Product Code | EYC |
| Date Received | 2013-05-20 |
| Returned To Mfg | 2013-05-06 |
| Catalog Number | 300416A |
| Device Availability | Y |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-20 |