MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-18 for COMPLETE CARE LUBRI-SIL I.C. * 303116A manufactured by C.r. Bard, Inc.
[19196512]
Patient had urinary catheter placed in the morning. Approximately four hours later, rn identified that the foley bag was leaking urine onto the floor. A small slit opening was found on the back of the catheter bag. Bag and tubing needed to be changed. What was the original intended procedure? Catheter insertion. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3073101 |
| MDR Report Key | 3073101 |
| Date Received | 2013-04-18 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-04-15 |
| Report Date | 2013-04-16 |
| Date Reported to FDA | 2013-04-18 |
| Date Reported to Mfgr | 2013-04-23 |
| Date Added to Maude | 2013-04-23 |
| 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 |
| 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 | COMPLETE CARE LUBRI-SIL I.C. |
| Generic Name | KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER |
| Product Code | FCN |
| Date Received | 2013-04-18 |
| Model Number | * |
| Catalog Number | 303116A |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC |
| Manufacturer Address | 730 CENTRAL AVE NEW PROVIDENCE NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-18 |