INJECTION NEEDLE MCL55-3 240MM BAYONET [MXI/XOM]
Received Mar 28, 2014 · Event occurred Feb 26, 2014
Report 9680837-2014-00021 · MDR key 3709371
Device
Generic name
Needle, Aspiration And Injection, Reusable
Manufacturer
Xomed Microfrance MfgModel number
MCL55-3Catalog number
MCL55-3
Lot number
131001
Product problems
- Break
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A 240MM BAYONET INJECTION NEEDLE BROKE. HOWEVER, ANALYSIS OF THE COMPLAINT DEVICE CONFIRMED THE BREAK RESULTED IN A 3CM DEVICE FRAGMENT THAT WAS NOT RETURNED BY THE CUSTOMER. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
(B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, THE DEVICE WAS RETURNED TO MEDTRONIC¿S INTERNATIONAL MANUFACTURING SITE FOR EVALUATION PURPOSES. THE INVESTIGATION REPORT FINDINGS ARE DETAILED AS FOLLOWS: THE NEEDLE IS BROKEN RIGHT AFTER THE LASER WELD¿THE SECOND PART WAS NOT RETURNED. NO MANUFACTURING OR MATERIAL DEFECT WAS OBSERVED. THE MOST PROBABLE CAUSE OF THIS BREAKAGE IS AN EXCESSIVE EFFORT DURING USE OR THE REPROCESSING OF THE INSTRUMENT. IT IS VERY FRAGILE AND IN THE CASE OF A DEFORMATION, IT IS IMPOSSIBLE TO STRAIGHTEN IT WITHOUT BREAKING THE TUBE. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.