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

Model Number 220531

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2020

Event Type  Injury  

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 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 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.

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.

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 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
• Type of Device: CULTURE MEDIA
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10165583
• MDR Text Key: 199987181
• Report Number: 1119779-2020-00150
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 30382902205310
• UDI-Public: 30382902205310
• Combination Product (y/n): N
• PMA/PMN Number: K042970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other