TISSUE-TEK UNI-CASSETTE 4155-02 M7321-32P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-18 for TISSUE-TEK UNI-CASSETTE 4155-02 M7321-32P manufactured by Sakura Finetex Usa.

Event Text Entries

[2291553] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2306122
• MDR Report Key: 2306122
• Date Received: 2011-10-18
• Date of Report: 2011-10-18
• Date of Event: 2011-08-03
• Report Date: 2011-10-18
• Date Reported to FDA: 2011-10-18
• Date Added to Maude: 2011-10-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TISSUE-TEK UNI-CASSETTE
• Generic Name: LAB SPECIMEN TISSUE-PROCESSING CONTAINER
• Product Code: KER
• Date Received: 2011-10-18
• Model Number: 4155-02
• Catalog Number: M7321-32P
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SAKURA FINETEX USA
• Manufacturer Address: 1750 WEST 214TH STREET TORRANCE CA 90501 US 90501

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-10-18