FDA.reportPublic FDA data

MAUDE MDR 2633754

MDR report key
2633754
Report number
2243969-2012-00038
Event key
0
Event type
3
Date of event
2012-05-25
Date received
2012-06-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ADRIENNE MCNALLY
Address
200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US
Phone
908-908-9089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHUR-CLENS - WOUND CLEANSERSHUR CLENS WOUND CLEANSERCONVATECKOYNA121222UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-2101. H

Event Narratives#

D

Patient 1

STATED PROBLEM: DON CALLED TO REPORT THAT A RESPIRATORY THERAPIST ACCIDENTALLY INSTILLED A 20 ML VIAL OF SHURCLENS INTO AN ET TUBE DURING A CODE SITUATION. THERE WAS FOAMING OF SOLUTION IN ET TUBE SO IT WAS SUCTIONED AND IRRIGATED MULTIPLE TIMES BEFORE PT TRANSFERRED. THIS IS A CRITICAL ACCESS HOSPITAL SO PT WAS IMMEDIATELY TRANSFERRED OUT TO (B)(6). FROM A CLINICAL PERSPECTIVE, THE EVENT OCCURRED IN THE EMERGENCY ROOM WHILST PT WAS IN RESPIRATORY ARREST AND WAS INTUBATED. A RESPIRATORY THERAPIST ACCIDENTALLY GRABBED THE AMPOULE OF SHURCLENS INSTEAD OF THE AMPULE OF NORMAL SALINE AND INSTILLED 20 MLS INTO THE ET TUBE. THERE WAS FOAMING IN THE ET TUBE AND IT WAS SUCTIONED AND IRRIGATED. PT'S CURRENT CONDITION IS UNK, AS SHE WAS IMMEDIATELY TRANSFERRED TO ANOTHER HOSPITAL AS PART OF HER PRE-PLANNED CARE NOT RELATED TO THIS EVENT. THIS AE IS DEEMED SERIOUS BECAUSE OF THE POSSIBILITY OF PT SUFFERING ASPIRATION OR CHEMICAL PNEUMONITIS FROM THE PRODUCT.