MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-01-27 for DYND50420 manufactured by Medline Industries, Inc..
[36892505]
It was reported that as the drain was being removed, it broke and the retained piece was manually removed. Multiple attempts have been made to gather additional information with very little response from the facility. We have not been provided many details regarding this incident. We were told that the drain was sutured in place. Nicking or cutting the drain can affect the integrity of the drain. No sample has been returned for evaluation. Without a sample, a root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
[36892506]
The drain broke upon removal and the retained piece was manually removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00006 |
| MDR Report Key | 5393056 |
| Report Source | USER FACILITY |
| Date Received | 2016-01-27 |
| Date of Report | 2016-01-27 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2016-01-27 |
| 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 | DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DRAIN, PENROSE |
| Product Code | EYZ |
| Date Received | 2016-01-27 |
| Catalog Number | DYND50420 |
| Lot Number | 6051411001 |
| 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 | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-27 |