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	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with the bd macro-vue¿ rpr card test, erroneous results were obtained.Erroneous results were reported to the clinician, but there was no patient impact.The following information was provided by the initial reporter: the negative control is again cloudy and also some of the sample so it is difficult to decide if the sample is positive or negative.The agglutination reagent have the same lot number in all kits.When you look at the tubes in the kits the liquid is with sedimentation /granular in it and it differs how much sedimentation is between tubes.
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Clarifying information provided by the initial reporter indicates that because of the issue with the negative control, the results were not considered valid and were not reported to a clinician.Testing was repeated with a new lot.The previous mfr report #2647876-2022-00230 should be considered canceled.
Event or Problem Description
It was reported that during use with the bd macro-vue¿ rpr card test, erroneous results were obtained.Erroneous results were reported to the clinician, but there was no patient impact.The following information was provided by the initial reporter: the negative control is again cloudy and also some of the sample so it is difficult to decide if the sample is positive or negative.The agglutination reagent have the same lot number in all kits.When you look at the tubes in the kits the liquid is with sedimentation /granular in it and it differs how much sedimentation is between tubes.

• 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: 15901602
• Report Number: 2647876-2022-00230
• Device Sequence Number: 12030047
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: (01)00382902750055
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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: 04/30/2024
• Device Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: 2094445
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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