MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM; MICROBIOLOGICAL SPECIMEN COLLECTION AND TRANSPORT DEVICE

Catalog Number	446255
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Laceration(s) (1946)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.No lot # provided.Device manufacture date: unknown.Investigation summary: bd molecular quality 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.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 for use with affirm atts.Bd molecular quality will continue to closely monitor for trends associated with affirm atts glass injury.
Event or Problem Description
It was reported that while using a bd affirm¿ vpiii ambient temperature transport system the technician was placing the sample tube into the device when sharp pieces of the glass ampule penetrated the wall of the device and cut the finger of the technician resulting in exposure to patient sample.The technician received a medical evaluation and was treated for exposure to bloodborne pathogens at an urgent care facility.

• Brand Name: BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
• Common Device Name: MICROBIOLOGICAL SPECIMEN COLLECTION AND TRANSPORT DEVICE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7946720
• Report Number: 9610847-2018-00327
• Device Sequence Number: 930921
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: 30382904462551
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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: Health Professional
• Device Catalogue Number: 446255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention