MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-23 for AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[41013201]
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 using the affirm atts kit. Previous investigations did not reveal any changes to materials that could directly cause this injury. A review of past complaints does not indicate a trend for the atts batch. Bd has implemented the atts reagent dropper dispensing tool in order to prevent future occurrence of this issue. Each kit of atts contains this tool and use of the atts reagent dropper dispensing tool when crushing the atts reagent dropper is outlined in the product instructions. Bd quality will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[41013202]
Customer reports that while squeezing the reagent ampule from the affirm vpiii ambient temperature transport one of their providers received a cut on her finger and some glass was embedded in the cut. Basic first aid was performed but glass remained in the cut. The injured provider sought medical attention from a physician and they decided to let the glass work it's way out on it's own. Multiple attempts have been made to obtain additional information but no response has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610847-2016-00001 |
| MDR Report Key | 5521170 |
| Date Received | 2016-03-23 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-03-03 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2015-12-10 |
| Date Added to Maude | 2016-03-23 |
| 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 | 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 | 0 |
| Brand Name | AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT |
| Generic Name | DEVICE, SPECIMEN COLLECTION |
| Product Code | LIO |
| Date Received | 2016-03-23 |
| Catalog Number | 446255 |
| Lot Number | 5337592 |
| Device Expiration Date | 2017-06-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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. Required No Informationntervention | 2016-03-23 |