MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-05 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Becton, Dickinson.
[16803700]
Customer reported a minor injury while running a pt sample on the affirm assay. A tech punctured her finger on a glass shard inside the specimen tube. The wound required basic first aid and the tech will received baseline testing.
Patient Sequence No: 1, Text Type: D, B5
[17048302]
The affirm atts collection kit is used to stabilize the nucleic acid of candida species, gardnerella vaginalis, and trichomonas vaginalis during specimen transport at ambient temperature (15-30 degrees celsius) or (2-8 degrees celsius) for up to 72h. Bd determined that in this situation that the customer did not follow the testing procedure. Per technical svs, the customer opened the tip of the plastic dropper when dispensing the atts solution into the sample tube. This allowed the glass to be poured into the sample tube. (b)(4) no corrective action will be initiated at this time. Bd will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00008 |
| MDR Report Key | 3625097 |
| Report Source | 05 |
| Date Received | 2014-02-05 |
| Date of Report | 2014-01-17 |
| Date of Event | 2014-01-17 |
| Date Mfgr Received | 2014-01-17 |
| Date Added to Maude | 2014-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | PERIFERICO LUIS DONALDO, COLODIO #579 |
| Manufacturer City | NOGALES, SONORA, C.P. 84000 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT |
| Product Code | LIO |
| Date Received | 2014-02-05 |
| Catalog Number | 446255 |
| Lot Number | 3038199 |
| Device Expiration Date | 2014-08-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON |
| Manufacturer Address | NOGALES, SONORA, C.P. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-05 |