MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD MACRO-VUE RPR CARD TEST; ANTIGENS, NONTREPONEMAL, ALL

Model Number	275005
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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 macro-vue¿ rpr card test a physical defect was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "the particles are too thick".
Additional Manufacturer Narrative
H6: investigation summary: serology test was performed and satisfactory results were obtained.Visual inspection and batch record review was performed no discrepancies were found.No photo or returned goods were available we were unable to reproduce customer experience.Complaint unconfirmed based on retention and batch record review.Although we are unable to reproduce customer claim, special attention should be provided to: antigen storage and use.Sample and room temperature during the test.Type of specimen used: collection and preparation.According of the ¿manual of test for syphilis¿ edition 9.0 the following ¿sources of error¿ had been identified for increase of reactivity or false reactivity for the rpr test.If the time of rotation is too long, test reactivity may be increased.If the card is excessively rotated and tilted (to and fro motions) by hand after removal from the rotator, a false reactive result may occur.If the serum is unevenly spread in the circle, the antigen and the antibody may not mix properly.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd macro-vue¿ rpr card test a physical defect was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "the particles are too thick.".

• Brand Name: BD MACRO-VUE RPR CARD TEST
• Common Device Name: ANTIGENS, NONTREPONEMAL, ALL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11941103
• Report Number: 3008352382-2021-00157
• Device Sequence Number: 16468029
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: PREAMENDMENT
• 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): 06/18/2021

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: 04/30/2022
• Device Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: 0092426
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1