MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY FLOCKED STERILE SWAB APPLICATORS; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Catalog Number 220527

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

Respiratory swab tip broke off in patient's nasal passage as this rn was swabbing pt for respiratory panel molecular assay.Dr.Was made aware and retrieved broken swab tip from pt's nasal passage.Lot number 1919129 exp 11/2021.Package of broken swab given to day charge rn.This device was removed by balloon extraction as a simple single-foreign body removal.

• Brand Name: FLOCKED STERILE SWAB APPLICATORS
• Type of Device: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10406956
• MDR Text Key: 202931153
• Report Number: 10406956
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 220527
• Device Lot Number: 1919129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Weight: 132