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

Model Number 220529

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd (b)(6) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.(b)(4).

Event Description

The customer reported while using the kit uvt 3ml with flocked minitip to collect a sample the tip of the swab broke off in the patients nose.The patient was sent to the emergency room for follow-up, and removal of the swab.The patient was released with no further issues or treatment needed.

Manufacturer Narrative

Investigation summary: the customer complaint is not confirmed.A review of the retention samples and dhr did not indicate any issues that would contribute to this defect.A physical stressing of the retention samples revealed that the swabs are within specification.No physical samples were available.A review of past complaints for this product does not indicate a trend on this issue.

Event Description

The customer reported while using the kit uvt 3ml with flocked minitip to collect a sample the tip of the swab broke off in the patients nose.The patient was sent to the emergency room for follow-up, and removal of the swab.The patient was released with no further issues or treatment needed.

• Brand Name: KIT UVT 3ML WITH FLOCKED MINITIP
• Type of Device: CULTURE MEDIA
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10278600
• MDR Text Key: 199438874
• Report Number: 2243072-2020-01069
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 30382902205297
• UDI-Public: 30382902205297
• 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
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Model Number: 220529
• Device Catalogue Number: 220529
• Device Lot Number: 200314400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other