FDA.reportPublic FDA data

MAUDE MDR 9539827

MDR report key
9539827
Report number
MW5091985
Event key
0
Event type
3
Date of event
2019-12-23
Date received
2019-12-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHILEY 8PERCTRACHEOSTOMY, TUBE (W/WO CONNECTOR)COVIDIENBTO8 PERC* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-310

Event Narratives#

D

Patient 1

SHILEY #8PERC TRACHEOSTOMY TUBE WAS PLACED ON (B)(6) 2019 AT 21:29 VIA PERCUTANEOUS PROCEDURE USING BRONCHOSCOPY BY (B)(6). ON (B)(6) 2019 RESPIRATORY THERAPIST WAS CALLED TO PATIENT BEDSIDE BY RN AND NOTED THAT THE TOP PART OF THE TRACH FLANGE HAD SEPARATED FROM THE TRACHEOSTOMY TUBE. PATIENT CURRENTLY ON MECHANICAL VENTILATION WITH NO LOSS OF VOLUME. THE PATIENT HAD COAGULATION ISSUES AND THERE WAS BLEEDING AT THE TRACH SITE. SUTURES WERE PLACED AROUND THE TRACH SITE BY (B)(6), AND A DECISION WAS MADE TO REPLACE THE TRACH TUBE NEXT DAY DUE TO COAGULATION ISSUES. ON (B)(6) 2019 AT 12:58 THE TRACHEOSTOMY TUBE WAS CHANGED VIA BRONCHOSCOPY WITH A SIZE 6 DCT. RESPIRATORY THERAPIST WAS TOLD BY ANOTHER NURSE OF A SIMILAR EVENT ON ANOTHER PATIENT WHERE AN 8PERC TRACH WAS CRACKED IN THE SAME PLACE AND WAS CHANGED TO A 6DCT. IT WAS ALSO DISCOVERED THAT ANOTHER RESPIRATORY THERAPIST HAS HAD AT LEAST 2 OTHER PERC TRACHS THAT WERE CRACKED ON INSERTION. NONE OF THESE TRACHEOSTOMY TUBES WERE SAVED OR REPORTED. FDA SAFETY REPORT ID # (B)(4).