MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-30 for BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC STRAPS 150719 manufactured by Productos Para El Cuidado De La Salud -9611590.
[54277921]
The device was not returned for evaluation. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use states the following: " position bag on leg with flutter valve at top. Attach catheter or extension tubing to top inlet. When wearing bag below knee, attach bard extension tubing (catalog no. 150615 or 4a4194). 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. " (b)(4). The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[54277922]
It was reported that the flutter valve was stuck together; as a result, the urine would not drain into the bag. The patient allegedly pushed on the bag, and urine was able to drain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2016-01158 |
| MDR Report Key | 5914107 |
| Date Received | 2016-08-30 |
| Date of Report | 2016-08-08 |
| Date Mfgr Received | 2016-08-08 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2016-08-30 |
| 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 | JANNA PARKS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC STRAPS |
| Generic Name | DRAIN BAG |
| Product Code | FAQ |
| Date Received | 2016-08-30 |
| Catalog Number | 150719 |
| Lot Number | NGZC4716 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Address | KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-30 |