MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for URO170816TS manufactured by Medline Industries Inc..
[145771578]
It was reported that after insertion of the urinary catheter, the cap of the urine meter was identified to have broken off. The urinary catheter was removed and replaced. No further incident was reported to the manufacturer. There was no impact or adverse effect to the patient or to the patient's stability related to the reported product issue. The sample involved in the reported incident was returned to the manufacturer for evaluation. Visual inspection confirmed the broken urine meter cap. The inner stem was found to be broken relatively flush with the top of the twist valve, suggesting it had broken off entirely from the urine meter connection point. There was no noted adhesive failure between the twist valve and inner stem and no defect or damage was apparent on the remainder of the sample. Based on the condition of the received sample it is suspected that a blunt force to the twist valve led to the component breaking off. Due to the reported need for medical intervention to remove and replace the urinary catheter, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145771579]
It was reported that after insertion of the urinary catheter, the cap of the urine meter was identified to have broken off. The urinary catheter was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00068 |
| MDR Report Key | 8626296 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-20 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TTL1LYR 16FR10ML 100%SIL TMPST TR |
| Product Code | OHR |
| Date Received | 2019-05-20 |
| Returned To Mfg | 2019-05-17 |
| Catalog Number | URO170816TS |
| Lot Number | 18KBN237 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600392753 US 600392753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-20 |