MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for FLEXAL 88TNF04L manufactured by Cardinal Health 200, Llc.
[137510212]
Gloves are ripping in the fingertips and cuffs. Absolutely not safe for chemotherapy administration or isolation rooms. Both boxes were by cardinal heath, the nitrile exam gloves (flexal) the first box had a lot # of 11a18l013 with a "ref" number at the top of the box (b)(4). The second box had a lot # of 11s18k508. Manufacturer response for nitrile exam gloves, (brand not provided) (per site reporter). Thank you for these additional details, having these lot #s will allow me to file a product quality report internally and we can then understand if this is an isolated issue or a more widespread occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8381402 |
| MDR Report Key | 8381402 |
| Date Received | 2019-03-01 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-02-24 |
| Report Date | 2019-02-28 |
| Date Reported to FDA | 2019-02-28 |
| Date Reported to Mfgr | 2019-03-01 |
| Date Added to Maude | 2019-03-01 |
| 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 | FLEXAL |
| Generic Name | POLYMER PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2019-03-01 |
| Model Number | 88TNF04L |
| Catalog Number | 88TNF04L |
| Lot Number | 11A18L013 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-03-01 |