BD SALINE FLUSH

Additional Manufacturer Narrative

AS NO PHYSICAL OR PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION, BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT THE BD SALINE FLUSH PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMMERCIAL REFERENCE: (B)(4). SET REFERENCE: (B)(4). BATCH/SERIAL NUMBER: (B)(6). EXPIRATION DATE: DATE OF OCCURRENCE: 04/11/2025. DESCRIPTION OF NON-COMPLIANCE: I INSERTED MY PATIENT'S IMPLANTABLE PORT THIS MORNING. LOOKING FOR REFLUX, I TRIED TO ASPIRATE WITH THE PRE-FILLED SYRINGE IN MY IMPLANTABLE PORT INSERTION KIT. WHEN ASPIRATING TO OBTAIN REFLUX, THE SYRINGE PLUNGER CAME OUT OF THE SYRINGE. THIS IMMEDIATELY CAUSED AIR TO ENTER THE ENTIRE GRIPPER TUBING. CONSEQUENCES: IMMEDIATE CLAMPING OF THE GRIPPER AND REMOVAL. DOCTOR NOTIFIED IMMEDIATELY. VITAL SIGNS CHECKED AND OK. NO SIGNS OF GAS EMBOLISM. DEVICE RETAINED FOR EXAMINATION: NO.

Additional Manufacturer Narrative

D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.