MAUDE MDR 3264014

MDR report key
3264014
Report number
3005477219-2013-00001
Event key
0
Event type
3
Date of event
2013-05-29
Date received
2013-07-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
VIA PEROTTI 16-18 BRESCIA 25125 IT
Phone
302-302-3026
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FLOQSWABSCOPAN FLOCK TECHNOLOGIESKXG503CS01503CS01I60U00R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-3001. R

Event Narratives#

D

Patient 1

A NASOPHARYNGEAL SWAB BROKE OFF AT THE TRANSITION POINT WHERE THE SHAFT CHANGES FROM THIN TO THICK IN (B)(6) ON (B)(6) AT PEDIATRICS. TWO NURSES WERE THERE FOR THE INCIDENT, ONE WAS PERFORMING NASOPHARYNGEAL COLLECTION WHILE THE OTHER WAS HOLDING THE CHILD LAYING IN THE SUPINE POSITION. SWAB WAS ROTATED MULTIPLE TIMES [DURING A SONG OF THE ABC'S - IN WHICH THE NURSE REACHED THE END OF THE ALPHABET BUT HAD NOT YET FINISHED THE SONG] FOR A TOTAL OF 10 SECONDS BEFORE THE NURSE FELT THE GIVE IN THE SWAB - INDICATING THE BREAK. THE CHILD WAS CRYING, BUT NOT THRASHING. WHEN THE SWAB BROKE, THE END STILL INSIDE THE PT WAS NOT VISIBLE. IT IS INDICATED IN THE DOCUMENTATION FROM THE ED THAT THE CHILD JERKED AND THAT IS WHEN THE SWAB BROKE. AFTER THE INCIDENT, THE CHILD DID NOT COUGH, GAG, OR APPEAR TO BE DISTRESSED IN ANY WAY. AS OF (B)(6), THE MOTHER CONFIRMED THAT THE CHILD HAD NOT COUGHED OUT THE SWAB OR PASSED IT IN HER STOOL. PT HAD A F/U APPOINTMENT ON (B)(6) BUT IT WAS AN ALREADY SCHEDULED APPOINTMENT AND WAS NOT IN REGARDS TO THE SWAB INCIDENT.

N

Patient 1

MFR INVESTIGATION REPORT: OUR ORIGINAL COMPLAINT INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTION OR DEFECT IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. THE DHR WAS REVIEWED AND NO ANOMALIES HAVE BEEN FOUND DURING ALL THE PRODUCTION STEPS.