MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-14 for OR TOWEL 17 X 24 IN., GREEN STERILE 28200-004 manufactured by Cardinal Health 200, Llc.
[179434364]
Disposable operating room towels used during endovascular case to drape patient and back table. Access was made with a micropuncture, which was flushed prior to use along with micropuncture sheath. When access was made into the vessel, and the micropucture sheath which had been inside the patient's blood vessel, was removed and replaced with a 5f sheath, the micropucture sheath was flushed and inside the lumen on the micropuncture sheath was approx 3/4-inch piece of green lint from the towels. Doctor was immediately notified. Careful observation was made to reduce potential for more linting on supplies. These towels, when trailed, were brought up due to concern of linting and adhering to wires, stents, etc. For endovascular cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710975 |
| MDR Report Key | 9710975 |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-23 |
| Report Date | 2020-01-29 |
| Date Reported to FDA | 2020-01-29 |
| Date Reported to Mfgr | 2020-02-14 |
| Date Added to Maude | 2020-02-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OR TOWEL 17 X 24 IN., GREEN STERILE |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2020-02-14 |
| Model Number | 28200-004 |
| Catalog Number | 28200-004 |
| Lot Number | 190924-04-SH |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |