MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-20 for BARD DISPOZ-A-BAG LEG BAG UNKNOWN manufactured by Productos Para El Cuidado De La Salud -9611590.
[55466644]
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: "- visually inspect the product for any imperfections or surface deterioration prior to use. If package is opened or damaged or if any imperfections or surface deterioration is observed, do not use. Important: hang drainage tube in a straight fashion from bedside to drainage bag. " (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
[55466645]
It was reported that urine was "sitting in the top of the drainage tubing" and was not flowing into the leg bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2016-01256 |
| MDR Report Key | 5963024 |
| Date Received | 2016-09-20 |
| Date of Report | 2016-08-29 |
| Date Mfgr Received | 2016-08-29 |
| Date Added to Maude | 2016-09-20 |
| 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 | 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 |
| Generic Name | LEG BAG |
| Product Code | FAQ |
| Date Received | 2016-09-20 |
| Catalog Number | UNKNOWN |
| 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 | 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 | 2016-09-20 |