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	08/17/2022
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 the antigen solution is too "grainy", and the reaction is too weak for both controls and patient samples.No patient impact.The following information was provided by the initial reporter: rpr 275005 - reaction is too weak.Followed up with the customer by phone; customer states that antigen solution is too "grainy", and the reaction is too weak for both controls and patient samples; customer ordered 3 kits of lot # 2013911, and they already used up the first kit, and opened the second one in hopes it is better but it is the same, too weak and grainy.
Additional Manufacturer Narrative
H.6 investigation summary: visual inspection was performed to retention samples, returned goods and no discrepancy were found.Batch record review do not show any discrepancy.Complaint unconfirmed based of retention, returned goods test results and batch history record review.Complaint unconfirmed 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.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd macro-vue¿ rpr card test the antigen solution is too "grainy", and the reaction is too weak for both controls and patient samples.No patient impact.The following information was provided by the initial reporter: rpr 275005 - reaction is too weak followed up with the customer by phone; customer states that antigen solution is too "grainy", and the reaction is too weak for both controls and patient samples; customer ordered 3 kits of lot # 2013911, and they already used up the first kit, and opened the second one in hopes it is better but it is the same, too weak and grainy.

• 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 ; 8015296192
• MDR Report Key: 15328171
• Report Number: 2647876-2022-00189
• Device Sequence Number: 12352736
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 09/18/2022

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: 01/31/2024
• Device Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: 2013911
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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