MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for ANGIOGRAPHY DRAPE S P PACK DYNJ44464C manufactured by Medline Industries, Inc..
[123589240]
Excessive linting was coming from the sterile towels from inside the sterile tray. Lint was discovered floating in the sterile saline in the bowl on the tray. Lint was found wrapped around a wire. A product defect form was filed. A product return form was completed. The wire with the lint wrapped around it was sent to medline for evaluation. Photos of lint in the sterile bowl were sent to the rep via email. Manufacturer response for sterile towels, medline angio tray (per site reporter). Manufacturer has both device itself and photos.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7960005 |
| MDR Report Key | 7960005 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-09-18 |
| Report Date | 2018-09-26 |
| Date Reported to FDA | 2018-09-26 |
| Date Reported to Mfgr | 2018-10-11 |
| Date Added to Maude | 2018-10-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIOGRAPHY DRAPE S P PACK |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2018-10-12 |
| Returned To Mfg | 2018-09-18 |
| Catalog Number | DYNJ44464C |
| Lot Number | 18FBU288 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1204 TOWNLINE RD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |