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 2018-07-18 for DYND13508 manufactured by Medline Industries Inc..
[114292021]
It was reported that the urethral catheter was being used to maintain tracheostomy stoma patency. Reportedly, the device became lodged in the patient's left bronchus and an unidentified procedure was required to remove the urethral catheter. After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient, product, or procedural information related to this incident. It was not identified how long the urethral catheter was in use for. It was not identified how the urethral catheter was secured to the tracheostomy stoma. No additional information related to this incident was reported to the manufacturer. No sample was returned to the manufacturer for evaluation. The reported use of the urethral catheter to maintain tracheostomy stoma patency is off-label use. Due to the reported incident, 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
[114292022]
It was reported that the urethral catheter was being used to maintain tracheostomy stoma patency. Reportedly, the device became lodged in the patient's left bronchus and an unidentified procedure was required to remove the urethral catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00061 |
| MDR Report Key | 7697751 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-18 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-07-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Generic Name | CATHETER,URETHRAL,REDRUBBER,STERILE,8FR |
| Product Code | EYB |
| Date Received | 2018-07-18 |
| Catalog Number | DYND13508 |
| 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 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-18 |