MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2016-11-04 for BARDIA 2000ML CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX 802001 manufactured by Productos Para El Cuidado De La Salud -9611590.
[59219854]
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: "remove protective cap from drainage tube and connect drainage tube adapter catheter. Fasten drainage bag to bedframe near the foot of the bed. Do not allow bag to touch floor, important: hang drainage tube in a straight fashion from bedside to drainage bag. If drainage bag is placed even with patient? S hip, coil tubing alongside patient. Tubing should be draped over patient? S leg. Check that urine is draining into bag. 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. " 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.
Patient Sequence No: 1, Text Type: N, H10
[59219855]
It was reported that the foley catheter disconnected from the sample port connector. Complainant alleged that she is using catheter 123516a with the drain bag. The catheter disconnections were reportedly causing urine to leak. The complainant allegedly experienced urinary tract infections, sepsis and methicillin-resistant staphylococcus aureus (mrsa) since using the drain bag. As a result, she has been prescribed antibiotics and has required hospitalization for treatment. It was also reported that the complainant was using anti-microbial wipes on the catheter and drain bag before and after use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2016-01562 |
| MDR Report Key | 6079436 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2016-11-04 |
| Date of Report | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Date Added to Maude | 2016-11-04 |
| 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 | 3 |
| Brand Name | BARDIA 2000ML CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX |
| Generic Name | DRAIN BAG |
| Product Code | FAQ |
| Date Received | 2016-11-04 |
| Catalog Number | 802001 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2016-11-04 |