MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-27 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Becton, Dickinson.
[4109450]
Customer complained that a technician cut her finger on shards of glass inside an affirm sample collection tube while processing a sample received from one of their collection sites. Due to improper collection at the clinical site, the sample contained shards of glass and the technician at the testing site cut her index finger while squeezing the tube to filter the sample. The technician received medical attention; it was determined the cut was minor and did not require sutures. The injury was treated by cleaning and has since healed. Baseline testing was performed on the technician for hiv and hepatitis; she will be rechecked in 6 months. A tetanus shot was also administered. The technician was wearing appropriate ppe at the time of the incident.
Patient Sequence No: 1, Text Type: D, B5
[11331154]
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 degree c) or (2-8 degree c) for up to 72h. Bd determined that in this situation, the glass ampule was inserted into the specimen transport tube. Package insert instructions for using the affirm atts system clearly indicate that only the liquid reagent from the ampule (and not the entire glass ampule) is to be added to the affirm specimen transport tube. A review of past complaints does not indicate this defect to be a confirmed trend. 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 | 1119779-2013-00012 |
| MDR Report Key | 3504138 |
| Report Source | 05 |
| Date Received | 2013-11-27 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-11-14 |
| Date Mfgr Received | 2013-11-14 |
| Date Added to Maude | 2013-12-09 |
| 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 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT |
| Product Code | LIO |
| Date Received | 2013-11-27 |
| Catalog Number | 446255 |
| Lot Number | UNK |
| 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 | 2013-11-27 |