MAUDE Adverse Event Report: BD CARIBE, LTD BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION; RPR ANTIGEN

Catalog Number	270309
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that while using bd macro-vue¿ rpr card antigen suspension, the antigen splashed in the eyes of the operator during use.Medical intervention required.
Additional Manufacturer Narrative
The customer complained of splash in their eyes.No laboratory test can be performed since lot number is unknown.The complaint history file for this product was verified and no other complaint were received with this customer claim.Safety data sheet was verified and it contains first aid measures for eye contact.¿after eye contact, rinse opened eye for 15 minutes under running water.Then consult your doctor¿.Product insert has warning notice in case product be in contact with the eyes.Although lot number was not provided by customer, drop test of the last lot of needle received in house was verified.Satisfactory results were obtain when drop test was performed.The complaint was unconfirmed by bd service personnel.Root cause unknown, lot number was not provided by customer.

• Brand Name: BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION
• Common Device Name: RPR ANTIGEN
• Manufacturer (Section D): BD CARIBE, LTD; vicks drive; lot no. 1; cayey
• MDR Report Key: 7060491
• Report Number: 2647876-2017-00002
• Device Sequence Number: 11102284
• Product Code: GMQ
• UDI-Device Identifier: 30382902703090
• UDI-Public: 30382902703090
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 270309
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention