MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2017-08-29 for AFFIRM VPIII MICROBIAL IDENTIFICATION TESTS 446252 manufactured by Becton Dickinson Caribe Ltd..
[83873396]
The bd 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 patients with symptoms of vaginitis/vaginosis. Bd has approved the use of the robogrip? Tool to assist in facilitating the expression of the contents of the affirm sample collection tube (sct) into the affirm reagent cassette for processing. This is achieved by providing leverage and transferring pressure from the user? S thumb to the user? S hand and stronger muscles of the lower arm. This tool (with accompanying instructions) is available to any affirm end user upon request. This customer was sent the robogrip? Tool in order to mitigate any further ergonomic issues in response to this complaint. Bd quality will continue to monitor for trends associated with ergonomic issues on affirm. (b)(4). Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[83873397]
The customer is reporting a strain to the right thumb due to the repetitive motion of squeezing the sample vial. The customer is using a thumb brace and contacted their employee health department. No further information has been provided regarding the employees strain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647876-2017-00001 |
| MDR Report Key | 6827028 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-08-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX CAROL NIETO |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | BECTON DICKINSON CARIBE LTD. |
| Manufacturer Street | VICKS DRIVE LOT NO. 6 |
| Manufacturer City | CAYEY PR |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII MICROBIAL IDENTIFICATION TESTS |
| Generic Name | AFFIRM VPIII MICROBIAL IDENTIFICATION TESTS |
| Product Code | LIO |
| Date Received | 2017-08-29 |
| Catalog Number | 446252 |
| Lot Number | UNKNOWN |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON CARIBE LTD. |
| Manufacturer Address | VICKS DRIVE LOT NO. 6 CAYEY PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-29 |