MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for COTTON BUDS 6" 13-018 manufactured by National Hospital Packaging.
[140000199]
The operating room purchases sterile packed items from (b)(6) hospital packaging, there are two problems. #1 packaging brittle, unable to open package and keep product sterile, package breaks and tears and won't peel open. Lot numbers 4098 & 5029. #2 some of the packages contain latex and others do not. Lot 5029 has a latex rubber band and lot 4098 does not. Both are same product number 13-018 and both have same ps#. Patient safety concern.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8455229 |
| MDR Report Key | 8455229 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-03-07 |
| Report Date | 2019-03-08 |
| Date Reported to FDA | 2019-03-08 |
| Date Reported to Mfgr | 2019-03-27 |
| Date Added to Maude | 2019-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | COTTON BUDS 6" |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | KXG |
| Date Received | 2019-03-27 |
| Model Number | 13-018 |
| Catalog Number | 13-018 |
| Lot Number | 5029 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL HOSPITAL PACKAGING |
| Manufacturer Address | 710 S. STIMSON AVE. CITY INDUSTRY CA 91745 US 91745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-27 |