MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for DYND160814 manufactured by Medline Industries Inc..
[139076546]
It was reported that a urine meter crack was identified and it began to leak. No additional sources of leakage were identified by the reporting facility. Reportedly, when the urine meter crack was identified, the urinary catheter was removed and replaced. According to the reporting facility, there was no impact or adverse effect to the patient or the patient's stability. The sample involved in the reported incident was returned to the manufacturer for evaluation. Visual inspection was performed and the inlet tubing connection was found to have fully cracked off from the rest of the urine meter with hairline fractures progressing outward from where the connection had broken off. The reported product issue was confirmed and the suspected root cause is a blunt force to the tubing connection (i. E. Drop, hit by bed, etc. ) that led to the inlet tubing connection cracking and subsequently breaking off. Due to the need for medical intervention to replace the urinary catheter, and in an abundance of caution, 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
[139076547]
It was reported that a urine meter crack was identified and that the patient's urinary catheter was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00028 |
| MDR Report Key | 8365920 |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date of Event | 2018-12-24 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-02-25 |
| 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 | 1LYR 14FR 10ML 100%SILI UM TRAY |
| Product Code | OHR |
| Date Received | 2019-02-25 |
| Returned To Mfg | 2019-02-20 |
| Catalog Number | DYND160814 |
| 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 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-25 |