MAUDE MDR 2306122

MDR report key
2306122
Report number
2306122
Event key
0
Event type
3
Date of event
2011-08-03
Date received
2011-10-18
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TISSUE-TEK UNI-CASSETTELAB SPECIMEN TISSUE-PROCESSING CONTAINERSAKURA FINETEX USAKER4155-02M7321-32P* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-10-180

Event Narratives#

D

Patient 1

A MALE WITH DOWN SYNDROME AND ACUTE MYELOGENOUS LEUKEMIA (AML) WAS ADMITTED FOR CHEMOTHERAPY. A BONE MARROW BIOPSY WAS PERFORMED ON DAY OF THE ADMISSION. THE PATHOLOGY DEPARTMENT PERFORMED A MICROSCOPIC EXAMINATION OF THE SPECIMEN AND THEN THEY SENT THE SPECIMEN TO A REFERENCE LABORATORY FOR HISTOLOGIC PROCESSING.THE REFERENCE LABORATORY CALLED AND INFORMED THEY COULD NOT FIND THE SPECIMEN. SOMETHING CAUSED THE CASSETTE TO OPEN AND THEY LOST THE SPECIMEN. THE HOSPITAL AND REFERENCE LABORATORIES SEARCHED FOR THE SPECIMEN, WHICH WAS WRAPPED IN "HISTO-WRAP" PAPER. THE SPECIMEN WAS NOT LOCATED. EVALUATION OF CASSETTE DETERMINED A POSSIBLE MANUFACTURER DEFECT. IT APPEARS THE TAB THAT SECURES THE CASSETTE IN A CLOSED POSITION EITHER BROKE OFF OR WAS MISSING. STAFF EVALUATED OTHER CASSETTES RECEIVED WITH THE SUSPECT CASSETTE, AND FOUND ANOTHER DAMAGED CASSETTE. NO OTHER REPORTS OF THIS PROBLEM HAVE BEEN SUBMITTED. I HAVE A PHOTOGRAPH OF THE CASSETTE TO SUBMIT TO MEDSUN. I ALSO HAVE A PHOTO OF THE NORMAL CASSETTE NEXT TO A DAMAGED ONE.WE ARE NOT RETURNING THE DAMAGED CASSETTE TO THE MANUFACTURER BECAUSE LABORATORY PERSONNEL FEEL THEY HAVE TO HAVE IT ON HAND IN CASE INSPECTORS COME TO HOSPITAL AND WANT TO EXAMINE DEVICES THAT WERE PROBLEMATIC.