ONS1733LL

Additional Manufacturer Narrative

COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

Description of Event or Problem

DR. (B)(6) HAS BEEN NOTICING SOME ISSUES LATELY WITH THE RETRIEVAL NEEDLES WE ORDER, AND THE CLINICAL STAFF NOTICED SOME CHANGES WITH THE TUBE PLUG AND CONNECTORS. DR. (B)(6) HAS ACTUALLY BEEN EXPERIENCING MORE BLEEDING AND A TYPE OF TEARING FROM THE NEEDLE THAT SHE HASN'T EXPERIENCED BEFORE, SHE IS VERY CONCERNED. SHE SAID THAT THE NEEDLES SOME THICKER AND SOMEHOW ROUGHER? I WILL HAVE HER TRY THE NEW LOT TOMORROW TO COMPARE IT, BUT THE CHANGES IN THE TUBING AND CONNECTORS MAKE ME THINK IT WILL BE THE SAME WITH THE NEEDLE. 1ST FOLLOW-UP ON (B)(6) 2022: NO RESPONSE. 2ND FOLLOW-UP ON (B)(6) 2022: I AM CURRENTLY AWAITING DR. (B)(6) REPLY TO THE QUESTIONS. BELOW, I WILL SEND ON THE INFORMATION AS SOON AS I RECEIVE IT. 3RD FOLLOW-UP ON (B)(6) 2022: NO RESPONSE. ADDITIONAL INFORMATION FROM (B)(6): IF THE NEEDLES ARE THICKER, ROUGHER OR NOT AS SHARP, THEY COULD CAUSE BLEEDING . I AM NOT SURE WHAT IT IS MEANT BY TEARING. TEARING OF WHAT? MORE INFORMATION FROM CUSTOMER ON THIS MATTER IS NEEDED. (B)(6). E-COMPLAINT: (B)(4).