MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-19 for LEG BAG WITH FLIP-FLO? VALVE 151932 manufactured by C.r. Bard, Inc. (covington) -1018233.
[95729856]
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: "1. Separate notches within circles. Pull straps through holes and around leg. 2. Position bag on leg with flutter valve at top. 3. Attach catheter or extension tubing to top inlet. When wearing bag below knee, attach bard? Extension tubing (catalog no. 150615 or 4a4194). When using extension tubing, make sure to connect tube at least to the 3rd taper of the connector. 4. To empty dispoz-a-bag? , push green lever on flip-flo? Valve out and down. Important: be sure to reclose flip-flo? Valve after emptying bag. 5. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable, local, state and federal laws and regulations. " (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[95729857]
It was reported that the intake valve of the drain bag became kinked; urine would not drain into the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-06384 |
| MDR Report Key | 7129690 |
| Date Received | 2017-12-19 |
| Date of Report | 2017-12-19 |
| Date Mfgr Received | 2017-11-27 |
| Date Added to Maude | 2017-12-19 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| 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 | 0 |
| Brand Name | LEG BAG WITH FLIP-FLO? VALVE |
| Generic Name | 32OZ LEG BAG |
| Product Code | FAQ |
| Date Received | 2017-12-19 |
| Catalog Number | 151932 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| 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 | 2017-12-19 |