MEDICHOICE LATEX FREE STOCKINETTE
Received Nov 11, 2011 · Event occurred Nov 11, 2011
Report 2344270 · MDR key 2344270
Device
Generic name
Sterile Stockinette
Manufacturer
Medichoice / Owens & MinorModel number
STK3648Catalog number
STK3648
Lot number
211211
Product problems
- Device Contamination with Chemical or Other Material
Patient
*
- No Patient Involvement
Narrative
Description of Event or Problem
FOREIGN MATERIAL DISCOVERED INSIDE OF A STERILE STOCKINETTE PACK WHILE PACK WAS IN CHANNEL OF DISTRIBUTION. FOREIGN MATERIAL: APPEARS TO BE A CLUMP OF LINT APPROXIMATELY 15 MM X 10 MM. SPD (STERILE PROCESSING DEPARTMENT) TECHNICIAN DISCOVERED PROBLEM AND REMOVED PRODUCT FROM DISTRIBUTION. JPG PHOTO CAN BE FORWARDED. (PLEASE ADVISE REPORTER OF E-MAIL ADDRESS; JPG WILL BE SENT OUT.)NO PATIENT ADVERSE EVENT AROSE SINCE PROBLEM WAS DISCOVERED PRIOR TO ANY PATIENT CONTACT.======================MANUFACTURER RESPONSE FOR STERILE STOCKINETTE, MEDICHOICE LATEX FREE STOCKINETTE (PER SITE REPORTER).======================NO RESPONSE AS OF THIS TIME. SENT E-MAIL TO SALES REP.