MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for SURE STEP FOLEY TRAY SYSTEM A303416A manufactured by C.r. Bard, Inc..
[41313779]
Patient Sequence No: 1, Text Type: N, H10
[41313780]
Rn reported bard stat lock to secure indwelling catheter was occluding the flow of urine into the urine meeter, as if it was clamped. The nurse reported 45 cc urine came out once the stat lock removed. She then used taped on the leg instead. The leg securement device called stat lock is part of the foley tray system. Manufacturer response for 16 fr sure step foley tray system, sure step foley tray system/ bard medical (per site reporter): the end user is not applying the tubing into the stat lock as instructed. There is only one way to put the tubing into the securement device and if the user puts tubing in the opposite direction this will crimp or occlude the outflow of urine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5531183 |
| MDR Report Key | 5531183 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-23 |
| Date of Event | 2015-12-15 |
| Report Date | 2016-03-23 |
| Date Reported to FDA | 2016-03-23 |
| Date Reported to Mfgr | 2016-03-23 |
| Date Added to Maude | 2016-03-29 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURE STEP FOLEY TRAY SYSTEM |
| Generic Name | BAG, URINE, COLLECTION |
| Product Code | NNW |
| Date Received | 2016-03-29 |
| Catalog Number | A303416A |
| Device Availability | N |
| Device Age | 0 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-29 |