MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-13 for BBL CULTURE SWAB * 22009 manufactured by Becton Dickinson.
[1101303]
Surgeon was using q-tip to culture wound through an arthroscopy incision. After insertion into incision, surgeon used twilling motion on q-tip handle. As the surgeon was attempting to remove the q-tip, about an inch of tip broke off into incision. Surgeon looked for the q-tip and had to make the incision bigger to debride the tissue and remove the q-tip.
Patient Sequence No: 1, Text Type: D, B5
[1266703]
Surgeon was using q-tip to culture wound through an arthroscopy incision. After insertion into incision, surgeon used twilling motion on q-tip handle. As the surgeon was attempting to remove the q-tip, about an inch of tip broke off into incision. Surgeon looked for the q-tip and had to make the incision bigger to debride the tissue and remove the q-tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1421096 |
| MDR Report Key | 1421096 |
| Date Received | 2009-07-13 |
| Date of Report | 2009-07-13 |
| Date of Event | 2009-06-30 |
| Report Date | 2009-07-13 |
| Date Reported to FDA | 2009-07-13 |
| Date Added to Maude | 2009-07-28 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL CULTURE SWAB |
| Generic Name | CULTURE & TRANSPORT SYSTEM |
| Product Code | JSL |
| Date Received | 2009-07-13 |
| Model Number | * |
| Catalog Number | 22009 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE; MC2266 FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-13 |