MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED REGULAR AND FLEXIBLE MINITIP; TRANSPORT CULTURE MEDIUM

Model Number	220527
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2020
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).Fda notified?: the initial reporter also notified the fda on (date) via medwatch # (b)(4).
Event or Problem Description
It was reported while using bd¿ universal viral transport kit, 3 ml, flocked regular and flexible minitip, to collect a sample the tip broke off in the patient¿s nasal cavity.Medical intervention was required to retrieve the broken swab tip.The patient did not experience any noticeable injury.
Event or Problem Description
It was reported while using bd¿ universal viral transport kit, 3 ml, flocked regular and flexible minitip, to collect a sample the tip broke off in the patient¿s nasal cavity.Medical intervention was required to retrieve the broken swab tip.The patient did not experience any noticeable injury.
Additional Manufacturer Narrative
H6: investigation summary the customer complaint is not confirmed.No returns or photos of the defect were available.An inspection of the retention samples and dhr did not indicate any issues.Both were satisfactory.A review of past complaints on this product for this issue does not indicate a confirmed trend.H3 other text : see h10.

• Brand Name: BD UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED REGULAR AND FLEXIBLE MINITIP
• Common Device Name: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 10666215
• Report Number: 1119779-2020-00709
• Device Sequence Number: 19487522
• Product Code: JSM
• UDI-Device Identifier: 30382902205273
• UDI-Public: 30382902205273
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K042970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/24/2021

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: 220527
• Device Catalogue Number: 220527
• Device Lot Number: 1919129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 07/16/2021
• 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