MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM; DEVICE, SPECIMEN COLLECTION

Catalog Number	446255
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: lot # for swab was not provided, however, the lot from the sampling kit was.Lot# b01c269m.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd molecular quality initiated investigation on the customer report regarding an incident where during patient specimen collection an affirm swab head detached.Quality investigation required vendor investigation.Our swab manufacturer (vendor) reviewed the batch history records for the batch in question and no discrepancies were noted.The vendor performed inspections and testing of retention materials from the report batch and no failures were encountered.Our vendor was unable to duplicate the report.The vendor reviewed the past year years of complaints against the swab product and there were no complaints related to swab head detachment.Bd reviewed the past year of complaints and there are no similar complaints, thus we believe this to be an isolated incident.Bd molecular quality will continue to closely monitor for trends associated with affirm swab head detachment.There was no corrective action taken at this time.
Event or Problem Description
It was reported while using bd affirm¿ vpiii ambient temperature transport system the swab tip broke off in patient's vagina.There was no report of patient impact.

• Brand Name: BD AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11143150
• Report Number: 1119779-2021-00058
• Device Sequence Number: 2210739
• Product Code: LIO
• UDI-Device Identifier: 00382904462550
• UDI-Public: 00382904462550
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K920536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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 Catalogue Number: 446255
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1