MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-18 for BBL CULTURE SWAB 220109 manufactured by .
[16638171]
Outpatient physician office returned unopened culture swab to lab with comment that they saw a brown residue on the bottom of the swabs. Pack was opened in microbiology and both swabs cultured. Subculture grew coagulase negative (b)(6) species. Vendor (b)(4) has been notified of the issue and remaining swabs of this lot number will be returned to them for an internal investigation. To date, it is unk if any pt results have been affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017157 |
| MDR Report Key | 1812246 |
| Date Received | 2010-08-18 |
| Date of Report | 2010-08-02 |
| Date of Event | 2010-07-30 |
| Date Added to Maude | 2010-08-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL CULTURE SWAB |
| Generic Name | LQ STUART DOUBLE PLASTIC APPLICATOR |
| Product Code | JSI |
| Date Received | 2010-08-18 |
| Returned To Mfg | 2010-08-06 |
| Catalog Number | 220109 |
| Lot Number | NFGE90 |
| Device Expiration Date | 2010-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-18 |