MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for BD ESWAB COLLECTION KIT REGULAR FLOCKED SWAB 220245 manufactured by Copan Italia.
[177154847]
Concern has arisen around the use of the becton dickinson throat swab. This swab is manufactured by (b)(4) and distributed by becton dickinson. The concern is that there is a pre-manufactured "break away" area along the shaft of the swab to allow the clinician to break off the tip, put it in the vial that comes in the package, and send the vial to the lab for testing. The concern is that the tip could break off while in use, especially when swabbing a child's throat. A child could easily bite down on the swab shaft causing it to break in the predetermined area and possibly get stuck in the child's throat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9652753 |
| MDR Report Key | 9652753 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-02 |
| Date of Event | 2020-01-02 |
| Report Date | 2020-01-02 |
| Date Reported to FDA | 2020-01-02 |
| Date Reported to Mfgr | 2020-01-31 |
| Date Added to Maude | 2020-01-31 |
| 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 | BD ESWAB COLLECTION KIT REGULAR FLOCKED SWAB |
| Generic Name | SYSTEM, TRANSPORT, AEROBIC |
| Product Code | JTW |
| Date Received | 2020-01-31 |
| Model Number | 220245 |
| Catalog Number | 220245 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN ITALIA |
| Manufacturer Address | 26055 JEFFERSON AVENUE MURRIETA CA 92562 US 92562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |