MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. KIT AFFIRM ATT SYSTEM 100 EA; DEVICE, SPECIMEN COLLECTION

Model Number	446255
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd molecular quality initiated investigation on a splashing event while processing an affirm atts ampule.Specifically, the end user experienced a splashing event while processing atts which resulted in a reagents into the eye.It is strongly recommended that the "procedures" on page #2 of the "bd affirm vp iii atts" package insert is reviewed with the end user to ensure the instructions are being strictly adhered to.Specifically, per instruction #3, the atts reagent dropper must be "inverted" into the sample collection tube before it is broken.There should be no chance of any splash to the eye if the end user is following this instruction.Please also ensure the end user is wearing required laboratory glasses (ppe).Finally, on page #17 of the package insert, a chart illustrating the instructions for use can be found.There are no current trends against atts splashing.Bd molecular quality will continue to closely monitor for trends associated with splashing events while processing an affirm atts ampule.There was no corrective action taken at this time.
Event or Problem Description
It was reported that while using kit affirm att system 100 ea the reagent splashed in the eye of the laboratory personnel.The customer stated there was no impact to the laboratory personnel.

• Brand Name: KIT AFFIRM ATT SYSTEM 100 EA
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11565988
• Report Number: 9610847-2021-00114
• Device Sequence Number: 19879525
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: 30382904462551
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K920536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 446255
• Device Catalogue Number: 446255
• Device Lot Number: B01C272M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1