MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) KIT PREPSTAIN CONSUME 480 TEST; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number	491454
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.D4: lot: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported kit prepstain consume 480 test expiration on outside of box was further out than expiration dates on the inside.The following information was provided by the initial reporter: customer states expiration on outside of box was further out than expiration dates on the inside.
Event or Problem Description
It was reported kit prepstain consume 480 test expiration on outside of box was further out than expiration dates on the inside.The following information was provided by the initial reporter: customer states expiration on outside of box was further out than expiration dates on the inside.
Additional Manufacturer Narrative
H.6.Investigation summary: the customer complained about an unknown lot of material 491454 having a conflicting expiration date from the subcomponents.Specifically, the customer stated that the expiration date on the outside of the box was further out than the expiration dates on the inside.However, the customer did not provide the lot number or expiration date reported on the outside of the kit, nor the expiration date(s) from the inside of the kit.A photo was not provided, nor was a sample returned by the customer.Therefore, the complaint is not confirmed.Material 491454 is produced at the bd mebane, nc facility by way of a manual pack out process in the kitting cell.No dhr review or retain analysis could be performed because no kit or subcomponent lot number was provided by the customer.The expiration date of the material 491454 is determined by subcomponent 700013131, precoat slides.Multiple lot numbers of 700013131 with different expiration dates can be used in a single production order of 491454, with the expiration date assigned to the kit being the expiration dates from the lots of 700013131 that expires the earliest.Therefore, a customer should not receive a kit that containing subcomponents with an expiration date earlier than what is labeled on the outside of the kit.A twelve-month complaint review for expiration dating issues was performed and identified no other complaints for kits containing an expiration date longer than the expiration date of the subcomponents.

• Brand Name: KIT PREPSTAIN CONSUME 480 TEST
• Common Device Name: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• 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: 17560450
• Report Number: 1119779-2023-00899
• Device Sequence Number: 19739510
• Product Code: MKQ
• UDI-Device Identifier: 00382904914547
• UDI-Public: 00382904914547
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P970018
• 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): 08/31/2023

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 Catalogue Number: 491454
• Device Lot Number: UNKNOWN
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown