MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-15 for AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM 446255 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[82755975]
Affirm? Vpiii ambient temperature transport system 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. Previous investigation did not reveal any changes to materials that could directly cause this injury. A review of past complaints does not indicate trend by atts batch. Bd has implemented the atts ampule crushing tool in order to prevent future occurrence of this issue. All current atts kits contain 1 tool which will be provided in each kit indefinitely. Bd strongly recommends use of this tool to eliminate chance of future injury. Bd will continue to closely monitor for trends associated with atts glass injury. (b)(4). Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[82755976]
The customer reported that while squeezing preservative from an ampule (contained in the affirm vpiii ambient temperature transport system kit) into an affirm specimen transport tube containing patient specimen, glass from the ampule pierced through the tube and injured a nurse practitioner's thumb. Practitioner needed to have glass surgically removed from her thumb under general anesthesia. Bd followed up with the customer on (b)(6) 2017 and the injured practitioner is doing well and cleared to go back to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2017-00063 |
| MDR Report Key | 6795716 |
| Date Received | 2017-08-15 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-08-15 |
| 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 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 SYSTEM |
| Generic Name | AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM |
| Product Code | LIO |
| Date Received | 2017-08-15 |
| Catalog Number | 446255 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| 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. Other | 2017-08-15 |