SEEDS MARKERS 351-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-14 for SEEDS MARKERS 351-1 manufactured by Best Medical International Inc..

Event Text Entries

[95081865] Best medical international inc. Has sent an instructions for use for a wire stripper that was not a legally marketed medical device. I (b)(6) it and found the same brand at (b)(6). When asked for 510k they could not produce one. We did not process. Recently sent seeds markers with revised instructions for use gas sterilization parameters. My machine is not set up for these parameters so i asked 3m. They stated that the parameters sent on the ifu are not validated by the fda for use with the 3m gas sterilizer 8xl by 3m and the company gives no parameters for autoclave yet state they can be. Eto states 480 min of exposure and 180 min of aeration. I am concerned that a less diligent sterile processing would not know to dig this deep. This company has the same paper for most of their products. I am concerned they are putting cancer patients and hospitals at risk. Has f-9. 065(7). The oncology department took the seed markers back stating they would return them. I hope they do.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5073976
• MDR Report Key: 7120637
• Date Received: 2017-12-14
• Date of Report: 2017-12-13
• Date Added to Maude: 2017-12-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SEEDS MARKERS
• Generic Name: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• Product Code: KXK
• Date Received: 2017-12-14
• Catalog Number: 351-1
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BEST MEDICAL INTERNATIONAL INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-12-14