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

Catalog Number	446255
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: 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 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 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: not confirmed.Customer education issue.Root cause description: off-label use.
Event or Problem Description
It was reported that a technician experienced a puncture from glass from a bd affirm¿ vpiii ambient temperature transport system during the filtering step of the process.

• Brand Name: BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
• Common Device Name: DIRECT TESTING/SEROLOGY
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7183459
• Report Number: 9610847-2017-00240
• Device Sequence Number: 1044251
• Product Code: LIO
• UDI-Device Identifier: 00382904462550
• UDI-Public: 00382904462550
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 01/03/2018

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: 11/24/2018
• Device Catalogue Number: 446255
• Device Lot Number: 7243600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/11/2018
• 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