NDL,TUOHY EPID,20GX6", METAL STYLET

Additional Manufacturer Narrative

THE CUSTOMER NOTIFIED MEDLINE INDUSTRIES, LP ON (B)(6) 2024 THAT THE NEEDLE IN QUESTION WAS NOT A COMPONENT FROM PAIN8010. ACCORDING TO THE CUSTOMER, THE COMPONENT THAT CAUSED THE REPORTED ISSUE CAME FROM A B BRAUN KIT THEREFORE THE INITIAL REPORTED ISSUE IS NOT RELATED TO PAIN8010 OR ANY OTHER PRODUCT MANUFACTURED BY MEDLINE INDUSTRIES, LP.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHEN ADMINISTERING A "PAIN BLOCK" THE NEEDLE "BROKE INSIDE THE PATIENT'S BACK". THE CUSTOMER REPORTED THE NEEDLE WAS "SUPERFICIAL", REMOVED UNDER "X-RAY GUIDANCE" WITH A "KELLY CLAMP", AND CLOSED WITH "DERMA BOND". THE CUSTOMER REPORTED THE PROCEDURE WAS ABLE TO BE COMPLETED AND AN "ANTIBIOTIC" WAS ADMINISTERED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHEN ADMINISTERING A "PAIN BLOCK" THE NEEDLE "BROKE INSIDE THE PATIENT'S BACK".