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 07/05/2020

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

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.

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 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
• Type of Device: CULTURE MEDIA
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10423567
• MDR Text Key: 204041920
• Report Number: 2243072-2020-01272
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 220529
• Device Catalogue Number: 220529
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other