MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-29 for BD AFFIRM VPIII MICROBIAL IDENTIFICATION TES 446257 manufactured by Bd Diagnostic Systems.
[873941]
Two technicians have been diagnosed and treated by a physician for carpal tunnel syndrome (cts). One tech was previously diagnosed and treated and had a relapse after using this kit to process 150 samples per day. The other tech was newly diagnosed, treated by their physician and removed from performing this test. The customer feels this is due to pealing back the foil covering to access the test reagents in the cassettes.
Patient Sequence No: 1, Text Type: D, B5
[8078932]
The affirm vpiii microbial identification test is a dna probe test intended for use in the detection and identification of candida species, gardnerella vaginalis and trichomonas vaginalis nucleic acid in vaginal fluid specimens from pts with symptoms of vaginitis/vaginosis. The reagent cassettes used for this test are covered with foil that must be pealed off to access the reagents. A cross-functional team has been constructed to evaluate this issue. They will investigate tools that can be used to facilitate the manual foil removal process. Several off the shelf tools have been identified and are being evaluated across multiple users. Add'l usability studies will be conducted following any select tool enhancements. If an acceptable tool cannot be found, a proposal for a project to develop a solution would be initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2008-00007 |
| MDR Report Key | 1053579 |
| Report Source | 05 |
| Date Received | 2008-05-29 |
| Date of Report | 2008-05-28 |
| Date of Event | 2008-04-29 |
| Date Mfgr Received | 2008-04-28 |
| Date Added to Maude | 2010-04-07 |
| 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 | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | BE DIAGNOSTIC SYSTEMS |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD AFFIRM VPIII MICROBIAL IDENTIFICATION TES |
| Product Code | JSY |
| Date Received | 2008-05-29 |
| Catalog Number | 446257 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Address | SPARKS MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-29 |