MANOMETER BOTTOM ASSEMBLY

Description of Event or Problem

IT WAS REPORTED THAT MANOMETER ARE LEAKING. VERBATIM: THE MANOMETER IS LEAKING. THERE IS A BUBBLE WHERE THE BOTTOM PORTION AND NEEDLE MEET WHEN USING PRESSURE. THIS IS AN OCCURRING WITH ALL DIFFERENT SIZES OF NEEDLES. I ALSO HAVE A VIDEO THAT SHOWS WHAT IS OCCURRING MORE CLEARLY, BUT NO PLACE TO SUBMIT ON CIF.

Additional Manufacturer Narrative

PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0504. PATIENT PROBLEM CODE: F26.

Additional Manufacturer Narrative

(B)(4) ADDITIONAL INFORMATION: THE MANOMETER ITSELF IS A COMPONENT PART AND NOT A FINISHED GOOD DEVICE. THE 806 FDA PACKET WAS UPDATED TO AMENDMENT 2 TO HIGHLIGHT THE MANOMETER REVISIONS. THERE IS NOT A SEPARATE FDA PACKAGE FOR THIS RECALL. THE FDA COORDINATOR (MARK E. CHAN) WAS SENT AMENDMENT 2 ON (B)(6) 2022) BY (B)(6) FROM BD. H3 OTHER TEXT : SEE MANUFACTURE NARRATION

Description of Event or Problem

IT WAS REPORTED THAT MANOMETER ARE LEAKING VERBATIM: THE MANOMETER IS LEAKING. THERE IS A BUBBLE WHERE THE BOTTOM PORTION AND NEEDLE MEET WHEN USING PRESSURE. THIS IS AN OCCURRING WITH ALL DIFFERENT SIZES OF NEEDLES. I ALSO HAVE A VIDEO THAT SHOWS WHAT IS OCCURRING MORE CLEARLY, BUT NO PLACE TO SUBMIT ON CIF.

Additional Manufacturer Narrative

(B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO AND ONE VIDEO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. VISUAL EVALUATION OF THE PICTURE AND VIDEO PROVIDED CONFIRMED THE REPORTED FAILURE MODE (LEAKAGE/ MATING ISSUE). A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001417185 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, A GROWING TREND IN REPORTS OF THIS FAILURE MODE WAS IDENTIFIED. A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE THESE DEFECTS. A VOLUNTARY RECALL PI-22-4423-FA WAS ISSUE FOR THE LEAK FAILURE MODE IN THE LUMBAR PUNCTURE TRAYS. PLEASE SEE ATTACHED RECALL NOTIFICATION LETTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT MANOMETER ARE LEAKING. VERBATIM: THE MANOMETER IS LEAKING. THERE IS A BUBBLE WHERE THE BOTTOM PORTION AND NEEDLE MEET WHEN USING PRESSURE. THIS IS AN OCCURRING WITH ALL DIFFERENT SIZES OF NEEDLES. I ALSO HAVE A VIDEO THAT SHOWS WHAT IS OCCURRING MORE CLEARLY, BUT NO PLACE TO SUBMIT ON CIF.