MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD UNIVERSAL VIRAL TRANSPORT STANDARD KIT; COLLECTION/TRANSPORT

Model Number	220221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
The customer reported that while using bd¿ universal viral transport std swab kit for sample collection the tip of the swab broke off in the patient¿s left nostril.The swab tip was removed during a scheduled surgery.Multiple attempts were made to obtain additional information with no response from the customer.
Additional Manufacturer Narrative
H6: investigation summary the customer complaint is not confirmed.The batch number provided does not match that of any within our records.A device history review could not be completed as the batch number does not match that of any within our records.The photo provided does not show a broken swab.A review of past complaints does not indicate a confirmed trend for this product.
Event or Problem Description
The customer reported that while using bd¿ universal viral transport std swab kit for sample collection the tip of the swab broke off in the patient¿s left nostril.The swab tip was removed during a scheduled surgery.Multiple attempts were made to obtain additional information with no response from the customer.

• Brand Name: BD UNIVERSAL VIRAL TRANSPORT STANDARD KIT
• Common Device Name: COLLECTION/TRANSPORT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10410476
• Report Number: 1119779-2020-00280
• Device Sequence Number: 2391757
• Product Code: JSM
• UDI-Device Identifier: 30382902202210
• UDI-Public: 30382902202210
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K042970
• 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,Followup
• Report Date (Section B): 01/27/2021

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?: Yes
• Operator of Device: Other
• Device Model Number: 220221
• Device Catalogue Number: 220221
• Device Lot Number: 005P14
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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: Other