MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED REGULAR AND FLEXIBLE MINITIP; TRANSPORT CULTURE MEDIUM

Model Number 220527

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2020

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).Fda notified?: the initial reporter also notified the fda on (date) via medwatch # (b)(4).

Event Description

It was reported while using bd¿ universal viral transport kit, 3 ml, flocked regular and flexible minitip, to collect a sample the tip broke off in the patient¿s nasal cavity.Medical intervention was required to retrieve the broken swab tip.The patient did not experience any noticeable injury.

Event Description

It was reported while using bd¿ universal viral transport kit, 3 ml, flocked regular and flexible minitip, to collect a sample the tip broke off in the patient¿s nasal cavity.Medical intervention was required to retrieve the broken swab tip.The patient did not experience any noticeable injury.

Manufacturer Narrative

H6: investigation summary the customer complaint is not confirmed.No returns or photos of the defect were available.An inspection of the retention samples and dhr did not indicate any issues.Both were satisfactory.A review of past complaints on this product for this issue does not indicate a confirmed trend.H3 other text : see h10.

• Brand Name: BD UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED REGULAR AND FLEXIBLE MINITIP
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 10666215
• MDR Text Key: 211100859
• Report Number: 1119779-2020-00709
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 30382902205273
• UDI-Public: 30382902205273
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 220527
• Device Catalogue Number: 220527
• Device Lot Number: 1919129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other