Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: 8640.16 - INJECTION CANNULA. ON 11/28/07 RICHARD WOLF MEDICAL INSTRUMENTS REC'D A MEDWATCH REPORT FROM CORPORATE HEADQUARTERS IN REGARDS TO A PRODUCT PROBLEM THAT OCCURRED IN ANOTHER COUNTRY, RICHARD WOLF MEDICAL INSTRUMENTS IS NOTIFYING THE US DISTRICT OF OCCURRENCE. ON 11/09/07 RICHARD WOLF GMBH BECAME AWARE OF THE PRODUCT PROBLEM. THE INITIAL REPORTER WAS THE SALES REP OF RICHARD WOLF GMBH. PER THE REPORTER, THIS IS THEIR INVESTIGATION AND EVALUATION: PRODUCT WAS INVESTIGATED AT R. WOLF GMBH AND RESULTS INDICATED THAT THE LASER WELDING BETWEEN CANNULA TUBE AND CANNULA HEAD WAS IMPROPERLY WELDED WHICH CAUSED THE CANNULA TUBE TO WEAKEN AND BREAK. IN THE CURRENT DESIGN THE CONSTRUCTION OF THE CANNULA HAS A LASER WELD SEAL BETWEEN TUBE AND HEAD. AN ADHESIVE APPLICATION TO PROVIDE A SEAL BETWEEN THE TWO COMPONENTS WILL BE CONSIDERED IN THE FUTURE ASSEMBLY OF THE INJECTION NEEDLE. INJECTION CANNULAS OF THIS MODEL SOLD IN 233 SINCE FEBRUARY 2003. WE ARE NOT AWARE OF ANY SIMILAR FAILURE WITH THIS DEVICE. INJECTION CANNULAS QUANTITY ON THE BASELINE REPORT IS FOR US DISTRIBUTION ONLY. CAUSE OF EVENT: IMPROPER LASER WELDING IN THE MANUFACTURING PROCESS.