MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2015-08-14 for AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[22995232]
Affirm vpiii ambient temperature transport is a sterile ready-to-use system intended for the collection, transport and preservation of vaginal specimens for use only with the affirm vpiii microbial identification test. The affirm vpiii ambient temperature transport system (atts) should be used with those specimens where transport times are expected to exceed 1 h at ambient temperature (15 - 30? C) or 4 h at refrigerated temperatures (2 - 8? C). Bd molecular quality initiated investigation on the customer report regarding glass user injury while dispensing an affirm sample tube. Quality investigation required review of the affirm atts procedure. If the plastic protective dropper bottle is not opened prior dispense of atts into the collection tube there is no feasible way for glass to enter the specimen tube. The root cause for this error is likely collection site's failure to follow instructions for use. Additionally, bd has began providing atts ampule crushing tools with the atts ampule kits. With this inclusion, bd has provided stuffers reinforcing the procedure or proper atts usage. Bd molecular quality will continue to closely monitor for trends associated with atts glass injury. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[22995233]
The customer reported that while processing an affirm vpiii ambient temperature transport tube which was inoculated with patient sample, a shard of glass pierced through the plastic and cut a technician's finger. The wound was cleaned out with soap and water, a bandage was applied and the technician sought medical attention for possible exposure to body fluid. The patient, who was the source of the sample, and the technician were both tested for (b)(6). All tests were negative. The customer reports that the technician has returned to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2015-00002 |
| MDR Report Key | 5003982 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2015-08-14 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-08-01 |
| Date Mfgr Received | 2015-08-05 |
| Date Added to Maude | 2015-08-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLOSIO NO. 579 |
| Manufacturer City | NOGALES |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT |
| Generic Name | DEVICE, SPECIMEN COLLECTION |
| Product Code | LIO |
| Date Received | 2015-08-14 |
| Catalog Number | 446255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Address | PERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-14 |