MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM

Catalog Number	446255
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a technician cut their finger while using a bd affirm¿ vpiii ambient temperature transport system exposing them to bodily fluids.Injury and medical intervention were reported.
Additional Manufacturer Narrative
Investigation summary: bd molecular quality previously investigated an end user, affirm atts glass user injury (finger puncture) during dispense of specimen at an affirm testing facility.It was stated 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 ampule (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 has completed an update to 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.Investigation conclusion: complaint not confirmed.

• Brand Name: BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
• Common Device Name: TRANSPORT SYSTEM
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7311692
• Report Number: 9610847-2018-00051
• Device Sequence Number: 19294582
• Product Code: LIO
• UDI-Device Identifier: 00382904462550
• UDI-Public: 00382904462550
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K920536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/25/2018
• Device Catalogue Number: 446255
• Device Lot Number: 7212779
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2018
• Supplement Date Received by Manufacturer: 02/25/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention