CODMAN HEPARIN FLUSHING NEEDLE

Additional Manufacturer Narrative

EXAMINATION REVEALED THERE WAS A MINIMAL AMOUNT OF SOLDER PRESENT IN THE JOINT. IT WAS DETERMINED THIS MAY HAVE BEEN CAUSED BY IMPROPER FLOW OF THE SOLDER DURING MFG. THIS MAY HAVE LEAD TO THE TIP BECOMING DISLODGED FROM THE NEEDLE. INENTORY OF THESE DEVICES WAS REVIEWED. X-RAY EXAMINATION OF SOLDER JOINTS AND PULL TESTING WAS CONDUCTED ON THE AVAILABLE STOCK AND ALL RESULTS WERE FOUND TO BE SATISFACTORY. THE RETURNED UNITS WERE CONSIDERED ISOLATED OCCURENCES. ADDITIONAL TEST PROGRAMS WHICH WILL DETECT INCOMPLETE SOLDERING OF THIS TYPE HAVE BEEN ADDED TO THE PROCESS OF MANUFACTURE AS A CORRECTIVE ACTION.

Description of Event or Problem

TWO HEPARIN FLUSHING NEEDLES WERE USED DURING A CARDIOVASCULAR PROCEDURE AND THE TIP END OF EACH NEEDLE FELL OFF. ONE TIP WAS RECOVERED, AND 1 TIP WAS NOT.