MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) KIT AFFIRM ATT SYSTEM 100 EA; DEVICE, SPECIMEN COLLECTION

Catalog Number	446255
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.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 while using kit affirm att system 100 ea that there was an atts ampule skin puncture- with patient sample.The following information was provided by the initial reporter: hazard, injury or erroneous results details customer reports reagent has cut staff while using.Caregiver injured while opening the affirm atts vial without use of the provided ampule opener.The glass ampule broke thru the plastic, cutting the caregiver's gloved finger.The caregiver was sent to the er for follow-up due to concerns that she may have come in contact with the patient sample swab via the cut sustained from the broken glass.Customer problem: customer is reporting reagent has cut staff while using.Affected lot number b02f016m.
Additional Manufacturer Narrative
H6.Investigation summary: bd integrated diagnostic solutions initiated investigation on the customer report regarding glass user injury while using the affirm atts (catalog # 446255), batch # b02f016m.Previous investigation did not reveal any changes to materials that could directly cause this injury.A review of past complaints does not indicate trend by atts batch.Bd implemented the packaging of the atts ampule crushing tool in order to prevent future occurrence of this issue.All current atts kits contain 1 tool which will be provided in each kit indefinitely.We will continue to closely monitor for trends associated with atts glass injury.
Event or Problem Description
It was reported that while using kit affirm att system 100 ea that there was an atts ampule skin puncture- with patient sample.The following information was provided by the initial reporter: hazard, injury or erroneous results details customer reports reagent has cut staff while using.Caregiver injured while opening the affirm atts vial without use of the provided ampule opener.The glass ampule broke thru the plastic, cutting the caregiver's gloved finger.The caregiver was sent to the er for follow-up due to concerns that she may have come in contact with the patient sample swab via the cut sustained from the broken glass.Customer problem: customer is reporting reagent has cut staff while using.Affected lot number b02f016m.

• Brand Name: KIT AFFIRM ATT SYSTEM 100 EA
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17925863
• Report Number: 1119779-2023-01099
• Device Sequence Number: 6804987
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: 30382904462551
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 12/06/2023

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: 05/31/2024
• Device Catalogue Number: 446255
• Device Lot Number: B02F016M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown