MAUDE Adverse Event Report: BD BD; UNIVERSAL VIRAL TRANSPORT

Model Number 220529

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/03/2020

Event Type  Injury  

Event Description

An (b)(6) male presented as an outpatient for a tube change in the vascular procedural area.Patient underwent pre procedural covid testing with a nasal swab.During the testing, the rn recognized that the swab broke off in the patient's nose and the end with cotton was retained in the patient's sinuses.The patient went to the emergency department for evaluation.The end of the swab was not seen, but a ct of the sinuses showed the swab present in the patient's sinuses.Ent was consulted.The ent physician performed a rhinoscopy on the patient and could observe the swab tip but was unable to retrieve it.Upon changing scopes, the patient stated he felt that he swallowed the swab tip.It was no longer visible to the ent physician.The patient was then able to have his vascular procedure performed and was discharged home with instructions to notify the physician with any concerns about symptoms related to swallowing the swab.

• Brand Name: BD
• Type of Device: UNIVERSAL VIRAL TRANSPORT
• Manufacturer (Section D): BD
• MDR Report Key: 10290426
• MDR Text Key: 199438989
• Report Number: 10290426
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2020

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: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: 220529
• Device Catalogue Number: 005C14
• Device Lot Number: 200789900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR