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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD FLOCKED STERILE SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE
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BECTON DICKINSON AND COMPANY BD FLOCKED STERILE SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE Back to Search Results
Model Number 220529
Device Problems Difficult to Remove (1528); Component Missing (2306)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/19/2020
Event Type  Injury  
Event Description
The patient arrived in the emd with acute on chronic congestive heart failure.The nurse was performing covid swab as per policy on this patient.Swab was inserted into left nostril and inserted to prescribed depth.The swab then twisted and removed after 10 seconds.After removing the swab, the tip was noted to be missing.The nurse had patient blow his nose without producing tip of swab.The physician was notified.The physician attempted to remove swab but was unsuccessful.Otorhinolaryngology was consulted and viewed the nostril with direct rhinoscopy.There was not evidence of the swab tip, but small strands of the cotton tip were found and removed.The patient remained in no acute distress throughout entire event.Fda safety report id# (b)(4).
 
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Brand Name
BD FLOCKED STERILE SWAB
Type of Device
APPLICATOR, ABSORBENT TIPPED, STERILE
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
sparks MD 21152
MDR Report Key10199946
MDR Text Key196772509
Report NumberMW5095219
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/22/2020
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 Date03/01/2022
Device Model Number220529
Device Lot Number2007566
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/25/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
Patient Weight92
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