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

Catalog 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	02/20/2024
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 while testing with bd macro-vue¿ rpr card test, non reactive results were obtained on samples that previously tested as reactive at another facility with a different rpr test.There was no health impact or consequences reported.
Event or Problem Description
It was reported while testing with bd macro-vue¿ rpr card test, non reactive results were obtained on samples that previously tested as reactive at another facility with a different rpr test.There was no health impact or consequences reported.
Additional Manufacturer Narrative
H.6.Investigation summary: material: 275005 batch 3009503.Customer reported: bd rpr discordant results vs rapid test from another manufacturer.Serology test, visual inspection and batch record review was performed to retention sample.No returned goods received; no photo was provided.Retention sample results: satisfactory results when retention samples were tested for performance using three (3) sera panel numbers of each reactivity.Control lot (3275853) customer batch number (3009503).Serum no's.1, 4, 9: all lots showed negative results.Serum no.15: all lots showed reactive results at 1:1 to 1:4 and reactive minimal at 1:8.Serum no.19: all lots showed reactive results at 1:1, reactive minimal at 1:2 to 1:4.Serum no.20: all lots showed reactive results at 1:1, reactive minimal at 1:2.Serum no's; 24, 25 and 33: all lots showed reactive minimal results at 1:1to 1:2 and non-reactive at 1:4.Batch 3009503 was used for cap syphilis serology survey, g-a 2023, showing good results on g-01 to g-05.Satisfactory results were obtained for product performance, complaint unconfirmed based of retention sample results and batch history record review.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.Bd id/ast plant quality will continue to closely monitor trends for this defect, including changes in severity and rate.H3 other text : see h.10.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18904316
• Report Number: 2647876-2024-00051
• Device Sequence Number: 9136139
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: (01)00382902750055
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: 01/31/2025
• Device Catalogue Number: 275005
• Device Lot Number: 3009503
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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