AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM 446255

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-10-18 for AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM 446255 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..

Event Text Entries

[57723972] 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 an end user, affirm atts glass user injury (finger puncture) during dispense of specimen at an affirm testing facility. It was confirmed that the end user found glass in the specimen collection tube. Quality investigation required review of the affirm atts package insert and affirm collection poster. Per review of the affirm package insert & collection poster, it was determined that the affirm collection site was not following the affirm atts package insert or affirm collection poster instructions. The collection site was crushing the atts glass ampoule (as instructed), opening the atts cap and pouring the glass into the affirm sample collection tube (not instructed). The affirm package insert and affirm collection poster does not instruct collection sites to open the atts vial and pour the glass into the collection tube. Bd will update the affirm collection poster to provide further clarification on the instructions of use with affirm atts. Bd molecular quality will continue to closely monitor for trends associated with affirm atts glass injury. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[57723973] The customer reported that while processing the specimen transport tube from a affirm vpiii ambient temperature transport system, glass pierced through the tube and caused a cut on a technician's finger. The tube was inoculated with patient specimen. Basic first aid was applied and the technician was sent to a medical provider. Testing for blood borne pathogen exposure was performed. One week after the injury, the tech followed-up with the medical provider and the wound healed. No further information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610847-2016-00034
MDR Report Key6036561
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2016-10-18
Date of Report2016-10-18
Date of Event2016-06-01
Date Mfgr Received2016-09-08
Date Added to Maude2016-10-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX CAROL NIETO
Manufacturer Street7 LOVETON CIRCLE
Manufacturer CitySPARKS MD 21152
Manufacturer CountryUS
Manufacturer Postal21152
Manufacturer Phone4103164000
Manufacturer G1BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
Manufacturer StreetPERIFERICO LUIS DONALDO COLOSIO NO. 579
Manufacturer CityNOGALES
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
Generic NameDEVICE, SPECIMEN COLLECTION
Product CodeLIO
Date Received2016-10-18
Catalog Number446255
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
Manufacturer AddressPERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-10-18

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