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 2020-03-13 for SURE STEP? FOLEY TRAY SYSTEM BARDEX? LUBRICATH? FOLEY CATHETER TRAY 909116M manufactured by C.r. Bard, Inc. (covington) -1018233.
[183521062]
The reported event was inconclusive, as the device was not returned for evaluation. However, a potential root cause for this failure mode could be kink inlet tube/no air vent/design issue. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: "precautions for use (8) avoid force on the connecting parts as they may be accidentally disconnect due to the weight of the drainage bag etc. And may cause urine spill. "
Patient Sequence No: 1, Text Type: N, H10
[183521063]
It was reported that the urine did not flow properly from the inlet tube into the drain bag meter on the second day after placement. The patient complained of abdominal pain. The user tried to move the tube but was concerned due to the patients complaint of pain. So far there have been about 30 such events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01801 |
| MDR Report Key | 9831479 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-13 |
| 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 | SURE STEP? FOLEY TRAY SYSTEM BARDEX? LUBRICATH? FOLEY CATHETER TRAY |
| Generic Name | URINE DRAINAGE BAG (CONOD) |
| Product Code | EZC |
| Date Received | 2020-03-13 |
| Catalog Number | 909116M |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-13 |