MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-01 for URO180816 manufactured by Medline Industries Inc..
[143701882]
It was reported that the foley catheter broke off and had to be surgically removed. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, or incident details to the manufacturer. The sample was received in used, unpackaged condition. The reported issue of a broken foley catheter was confirmed through visual inspection of the received sample, through the presence of a cut across the shaft and a tear in the balloon. There is no definitive root cause for the tears at this time. However, based on the appearance of the received sample, it is suspected that an external force punctured the silicone material, leading to the observed tears. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[143701883]
It was reported that the foley catheter broke off and had to be surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00062 |
| MDR Report Key | 8569166 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-05-01 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TTLVENT 16FR10ML 100%SIL UM TR |
| Product Code | OHR |
| Date Received | 2019-05-01 |
| Returned To Mfg | 2019-04-09 |
| Catalog Number | URO180816 |
| Lot Number | UNK |
| 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 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-01 |