MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-18 for FLOQSWABS 086M49 L. TVP400 503CS01 manufactured by Copan Flocktechnologies.
[33841818]
Patient Sequence No: 1, Text Type: N, H10
[33841819]
Rn was doing a nasopharyngeal swab for flu/respiratory virus panel that md had ordered. Upon removing the nasopharyngeal swab from the nose, the nurse saw that the swab had broken off with approximately two inches missing off the end. Md was notified and attempted to remove without success. The plan was then to consult ent team however, patient's condition continued to deteriorate and family decided to remove patient from life support. The patient died the following day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5309756 |
| MDR Report Key | 5309756 |
| Date Received | 2015-12-18 |
| Date of Report | 2015-12-17 |
| Date of Event | 2015-12-10 |
| Report Date | 2015-12-17 |
| Date Reported to FDA | 2015-12-17 |
| Date Reported to Mfgr | 2015-12-17 |
| Date Added to Maude | 2015-12-18 |
| 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 |
| 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 | FLOQSWABS |
| Generic Name | APPLICATOR, SWAB, NASAOPHARYNGEAL, STERILE |
| Product Code | KCJ |
| Date Received | 2015-12-18 |
| Model Number | 086M49 L. TVP400 |
| Catalog Number | 503CS01 |
| ID Number | MDD CE 0123 |
| Device Expiration Date | 2017-12-01 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCKTECHNOLOGIES |
| Manufacturer Address | 26055 JEFFERSON AVENUE MURRIETA CA 92562 US 92562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-18 |