MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for URO170716 manufactured by Medline Industries Inc..
[145771628]
It was initially reported that the reporting facility had an unknown number of leaking catheters, that the drain bag that hooks to hang on the beds were breaking off, that the facility tried to change the drain bag into a leg bag and they could not get the tubing out of the catheter, and that zero urine was draining from a patient. In relation to these reports, an incident was reported where the facility had ended up having to remove the foley catheter and re-insert a new foley catheter. Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural/event details. Due to the reported medical intervention of foley catheter exchange, this medwatch is being filed. A sample is not available to be returned for evaluation. A definitive root cause for the reported issues could not be identified at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145771629]
Multiple foley catheter issues were reported and a patient reportedly required a foley catheter exchanged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00069 |
| MDR Report Key | 8600350 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-05-10 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TTL1LYR 16FR10ML 100%SILI DB TRA |
| Product Code | OHR |
| Date Received | 2019-05-10 |
| Catalog Number | URO170716 |
| Lot Number | 18EBE603 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-10 |