MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD UNIVERSAL VIRAL TRANSPORT STANDARD KIT; COLLECTION/TRANSPORT

Model Number 220221

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/22/2020

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 that while using bd¿ universal viral transport std swab kit for sample collection the tip of the swab broke off in the patient¿s left nostril.The swab tip was removed during a scheduled surgery.Multiple attempts were made to obtain additional information with no response from the customer.

Manufacturer Narrative

H6: investigation summary the customer complaint is not confirmed.The batch number provided does not match that of any within our records.A device history review could not be completed as the batch number does not match that of any within our records.The photo provided does not show a broken swab.A review of past complaints does not indicate a confirmed trend for this product.

Event Description

The customer reported that while using bd¿ universal viral transport std swab kit for sample collection the tip of the swab broke off in the patient¿s left nostril.The swab tip was removed during a scheduled surgery.Multiple attempts were made to obtain additional information with no response from the customer.

• Brand Name: BD UNIVERSAL VIRAL TRANSPORT STANDARD KIT
• Type of Device: COLLECTION/TRANSPORT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10410476
• MDR Text Key: 205086180
• Report Number: 1119779-2020-00280
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 30382902202210
• UDI-Public: 30382902202210
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 220221
• Device Catalogue Number: 220221
• Device Lot Number: 005P14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other