MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for DYNJ49372A manufactured by Medline Industries Inc..
[106612313]
It was reported that the operating (or) towel shed lint during an unidentified cath lab procedure. Per the facility, linting was discovered on an unidentified device after it was wiped with the towel. It is unknown at what point in the procedure the reported towel linting occurred. Per the facility, there was no effect on patient stability. No impact to the procedure was reported. No serious injury, follow-up care, or medical intervention was reported. A sample was received by the manufacturer and the reported product issue was confirmed. Despite good faith efforts to obtain additional information, the facility contact was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer. Due 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
[106612314]
It was reported that the operating room (or) towel shed lint during an unidentified cath lab procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00017 |
| MDR Report Key | 7439949 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-03-28 |
| Date Added to Maude | 2018-04-18 |
| 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 |
| 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 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | ANGIO TRAY |
| Product Code | OEQ |
| Date Received | 2018-04-18 |
| Returned To Mfg | 2018-03-29 |
| Catalog Number | DYNJ49372A |
| Operator | PHYSICIAN |
| 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. Other | 2018-04-18 |