MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD MAX UVE SPECIMEN COLLECTION KIT; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

Model Number	443376
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd max¿ uve specimen collection kit incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the client notes that the expiration date is different in the media from the one reported in the collection swab from the one reported on the package.".
Additional Manufacturer Narrative
This mdr should be considered cancelled.This type of kit has an expiration date on the components and a separate expiration date for the kit as a whole.This is not a product error and the expiration date on the kit should be followed.
Event or Problem Description
It was reported that while using bd max¿ uve specimen collection kit incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the client notes that the expiration date is different in the media from the one reported in the collection swab from the one reported on the package.".

• Brand Name: BD MAX UVE SPECIMEN COLLECTION KIT
• Common Device Name: TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 12178034
• Report Number: 9610847-2021-00330
• Device Sequence Number: 13860966
• Product Code: OUY
• UDI-Device Identifier: 30382904433766
• UDI-Public: 30382904433766
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 11/19/2021
• Device Model Number: 443376
• Device Catalogue Number: 443376
• Device Lot Number: 0063350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1