MAUDE Adverse Event Report: BECTON, DICKINSON & CO. KIT UVT 3ML WITH FLOCKED MINITIP; CULTURE MEDIA

Model Number	220529
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/19/2020
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
It was reported while using a kit uvt 3ml with flocked minitip to collect a sample the tip broke off in the patients nasal cavity.Several follow-up attempts were performed to obtain additional information, but there was no response from the customer.It is unknown if further medical intervention or treatment was required.
Additional Manufacturer Narrative
H6: investigation summary the customer complaint is not confirmed.No returns or photos were provided.An investigation of the retention samples and dhr were satisfactory.A physical stress test of the retention samples showed the swabs to be within specification.A review of past complaints for this product does not indicate a confirmed trend on this issue.
Event or Problem Description
It was reported while using a kit uvt 3ml with flocked minitip to collect a sample the tip broke off in the patients nasal cavity.Several follow-up attempts were performed to obtain additional information, but there was no response from the customer.It is unknown if further medical intervention or treatment was required.

• Brand Name: KIT UVT 3ML WITH FLOCKED MINITIP
• Common Device Name: CULTURE MEDIA
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10252324
• Report Number: 1119779-2020-00205
• Device Sequence Number: 753944
• Product Code: JSM
• UDI-Device Identifier: 30382902205297
• UDI-Public: 30382902205297
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/28/2021

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: 220529
• Device Catalogue Number: 220529
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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