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	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with the bd macro-vue¿ rpr card test, false results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: box 5/6 of the reagent that arrived on 02-07-2023 from rpr was opened, the first vial of the three that comes in the box was used.A reactive sample was analyzed, which was titrated, and it presented persistent agglutination up to the titer 1/1028.Given this situation, we proceeded to analyze non-reactive peec samples, and at the time of analysis, they presented weak agglutination or aggregation.A second vial from the same box was used and the process was repeated, concluding in the same situation.Finally, a vial from another box was used, and it was reprocessed with the non-reactive peec sample, obtaining the non-reactive result, concluding that the reagents in that box were possibly defective.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2647876-2023-00038 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that during use with the bd macro-vue¿ rpr card test, false results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: box 5/6 of the reagent that arrived on (b)(6) 2023 from rpr was opened, the first vial of the three that comes in the box was used.A reactive sample was analyzed, which was titrated, and it presented persistent agglutination up to the titer 1/1028.Given this situation, we proceeded to analyze non-reactive peec samples, and at the time of analysis, they presented weak agglutination or aggregation.A second vial from the same box was used and the process was repeated, concluding in the same situation.Finally, a vial from another box was used, and it was reprocessed with the non-reactive peec sample, obtaining the non-reactive result, concluding that the reagents in that box were possibly defective.

• 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
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17148372
• Report Number: 2647876-2023-00038
• Device Sequence Number: 5578123
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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 Expiration Date: 11/30/2023
• Device Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: 1306301
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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