MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED MINITIP; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Model Number 220529

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported while using a kit uvt 3ml with flocked minitip to collect a sample the tip broke off in the patients nasal cavity.Several follow-up attempts were performed to obtain additional information, but there was no response from the customer.It is unknown if further medical intervention or treatment was required.

Event Description

It was reported while using a kit uvt 3ml with flocked minitip to collect a sample the tip broke off in the patients nasal cavity.Several follow-up attempts were performed to obtain additional information, but there was no response from the customer.It is unknown if further medical intervention or treatment was required.

Manufacturer Narrative

H6: 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.

• Brand Name: BD UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED MINITIP
• Type of Device: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10257587
• MDR Text Key: 200034193
• Report Number: 1119779-2020-00206
• 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: 07/10/2020
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other