MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-02-20 for BARD? CLOSED SYSTEM URINARY DRAINAGE BAG 153509 manufactured by C.r. Bard, Inc. (covington) -1018233.
[180332105]
The reported event was inconclusive, as the device was not returned for evaluation. However, a potential failure mode could be? Bag will not expand/vinyl stuck together? With a potential root cause of? Static or positive air pressure.? 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: "visually inspect the product for any imperfections or surface deterioration prior to use. If package is opened or if any imperfection or surface deterioration is observed, do not use. "
Patient Sequence No: 1, Text Type: N, H10
[180332106]
It was reported that when the patient moved the bag around, the urine came back up into the tube. The complainant confirmed that the bag was not being held upside down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01225 |
| MDR Report Key | 9734638 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-20 |
| 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 | 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 | BARD? CLOSED SYSTEM URINARY DRAINAGE BAG |
| Generic Name | DRAIN BAG |
| Product Code | KNX |
| Date Received | 2020-02-20 |
| Model Number | 153509 |
| Catalog Number | 153509 |
| 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 | 2020-02-20 |