MAUDE Adverse Event Report: BECTON DICKINSON 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	07/05/2020
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
The customer reported while using the kit uvt 3ml with flocked minitip for sample collection the tip of the swab broke off in the patients nose.The patient received an ent consult with a nasal endoscopy and a ct chest scan for foreign bodies.It is assumed that the tip was swallowed, but could not be confirmed.
Additional Manufacturer Narrative
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.H3 other text : see h.10.
Event or Problem Description
The customer reported while using the kit uvt 3ml with flocked minitip for sample collection the tip of the swab broke off in the patients nose.The patient received an ent consult with a nasal endoscopy and a ct chest scan for foreign bodies.It is assumed that the tip was swallowed, but could not be confirmed.

• Brand Name: KIT UVT 3ML WITH FLOCKED MINITIP
• Common Device Name: CULTURE MEDIA
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10423567
• Report Number: 2243072-2020-01272
• Device Sequence Number: 14229356
• 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: 07/22/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 08/18/2020
• 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