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

Catalog Number	446255
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Injury (2348)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd molecular quality investigated an end user, affirm atts glass user injury (finger puncture) during dispensing 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.Investigation conclusion: complaint not confirmed.Root cause description: end user not following procedure.Rationale: complaint not confirmed.No trend (<3 complaints against indicated failure mode for given month).
Event or Problem Description
This report represents patient 2 of 2: it was reported while using a bd affirm¿ vpiii ambient temperature transport system, the lab technician broke the glass ampule with a reagent dropper.However, after breaking the glass ampule, the lab technician removed the cap and poured the contents into a sample collection tube.The technician did not notice the glass shards in the tube and cut their fingers while squeezing the collection tube.The lab technician was exposed to patient sample through the cuts in their fingers.The lab technician was treated with first aid on site which included rinsing the injury site and bandaging their wounds.Post exposure, the lab technician was tested and then monitored for hiv and hepatitis.No indication was given that the patient had contracted a blood bourne illness from the exposure.The following information was provided by the initial reporter: "customer reports two injuries due to the glass ampule in the atts kit.The customer states they were receiving samples from collection sites where the collection sites have correctly broken the glass ampule using the reagent dropper but have removed the cap and poured the contents into the transport/sample collection tube with the patient specimen.The lab explains that they did not notice the glass shards inside the tube and cut their fingers when squeezing the collection tubes as well as when adding the filter tip.End users required only on-site first aid, including rinsing the puncture site and adhering a band aid.End users were potentially exposed to patient bodily fluids and are being monitored and tested for hiv and hepatitis.".

• Brand Name: BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
• Common Device Name: 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: 8588897
• Report Number: 9610847-2019-00359
• Device Sequence Number: 2339423
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: 30382904462551
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 446255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/07/2019
• 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