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

Model Number	275005
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the product label information does not match sds with bd macro-vue¿ rpr card test.
Additional Manufacturer Narrative
H6: investigation summary: carton label is not in accordance with the sds.Sds classification of chemicals changed so pictograms and h codes are different now.A device history review could not be completed as no batch number was provided.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.We are in the process of updating the carton label and the package insert as well.The change of this carton label is expected to be completed in the next 180 days.Product form, function or materials were not change.Complaint confirmed based on sds and carton label evaluation.
Event or Problem Description
It was reported that the product label information does not match sds with bd macro-vue¿ rpr card test.

• 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: 11386568
• Report Number: 3008352382-2021-00059
• Device Sequence Number: 3513265
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 03/09/2021

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 Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1