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

Model Number	220531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/18/2020
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 that while a patient was in the labor and delivery, they requested to be tested for covid prior to discharge.A nasopharyngeal sample was taken using a swab from a kit uvt 3ml with flocked flex minitip.The nurse performed the nasopharyngeal collection with the swab and upon pulling the swab out of the nares, noted a portion of the swab was missing.The patient was directed to a physicians office immediately after discharge where the retained portion was removed intact.The patient did not experience any noticeable injury, and no additional follow-up was required.
Event or Problem Description
It was reported that while a patient was in the labor and delivery, they requested to be tested for covid prior to discharge.A nasopharyngeal sample was taken using a swab from a kit uvt 3ml with flocked flex minitip.The nurse performed the nasopharyngeal collection with the swab and upon pulling the swab out of the nares, noted a portion of the swab was missing.The patient was directed to a physicians office immediately after discharge where the retained portion was removed intact.The patient did not experience any noticeable injury, and no additional follow-up was required.
Additional Manufacturer Narrative
The following fields were corrected with additional information: d.4.Catalog number: 220526; lot number: 200904000.D.4.Medical device expiration date: 2021-09-30.H.4.Medical device manufacture date: 2020-04-09.
Additional Manufacturer Narrative
Investigation summary: the customer complaint is not confirmed.A review of the retention samples and dhr does not reveal the noted defect.A physical stressing of the swabs showed them to be within specification.No returns were available.A review of past complaints does not indicate a trend on this issue.H3 other text : see h.10.
Event or Problem Description
It was reported that while a patient was in the labor and delivery, they requested to be tested for covid prior to discharge.A nasopharyngeal sample was taken using a swab from a kit uvt 3ml with flocked flex minitip.The nurse performed the nasopharyngeal collection with the swab and upon pulling the swab out of the nares, noted a portion of the swab was missing.The patient was directed to a physicians office immediately after discharge where the retained portion was removed intact.The patient did not experience any noticeable injury, and no additional follow-up was required.

• Brand Name: KIT UVT 3ML WITH FLOCKED FLEX MINITIP
• Common Device Name: CULTURE MEDIA
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10165583
• Report Number: 1119779-2020-00150
• Device Sequence Number: 2152998
• Product Code: JSM
• UDI-Device Identifier: 30382902205310
• UDI-Public: 30382902205310
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,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?: No
• Operator of Device: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 220531
• Device Catalogue Number: 220526
• Device Lot Number: 200904000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/12/2020; 01/26/2021
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/27/2020; 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