INJECTION NEEDLE MCL55U 250MM MALLEABLE
Received Aug 29, 2013 · Event occurred Feb 10, 2010
Report 9680837-2013-00082 · MDR key 3337559
Device
Manufacturer
Medtronic Xomed Instrumentation S.a.s.Model number
MCL55UProduct problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ML55U (QTY 21 - LOT:UNK) - MFG DATE:UNK. (B)(6). EVALUATION OF THE DEVICE INDICATED THAT THE NEEDLES WERE BROKEN AND/OR BENT. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED I THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. MXI CAPA (B)(4) WAS OPENED TO ADDRESS THESE ISSUES. (B)(4).
Description of Event or Problem
TWENTY TWO DEVICES (PART#: MCL55U) WERE RETURNED TO MXI SVC AND REPAIR.