PENCAN®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT A SPINAL NEEDLE (MATERIAL 333875, LOT 0061795871) WAS BEING USED TO ADMINISTER MEDICATION ON AN UNSPECIFIED DATE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, 25G SPINAL NEEDLE BROKE WHEN WITHDRAWN OUT OF THE INTRODUCER NEEDLE. INTRODUCER NEEDLE THEN WITHDRAWN, AND THE REST OF THE SPINAL NEEDLE CAME OUT WITH THE INTRODUCER. THE REST OF THE SPINAL NEEDLE WAS INTACT. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.