BD SALINE FLUSH

Additional Manufacturer Narrative

H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

T WAS REPORTED THAT THE BD SYRINGE 10ML SALINE FILL CE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SUBJECT: PRODUCT COMPLAINT POSIFLUSH SP 10ML LOT 5344518 GOOD AFTERNOON, I HEREBY WISH TO PASS ON A PRODUCT COMPLAINT REGARDING POSIFLUSH SP 10ML SYRINGES. WE RECEIVED THE COMPLAINT BELOW, SEE BELOW. AFTER INVESTIGATION, IT APPEARS THAT: - FIRST INCIDENT OCCURRED 1.5 YEARS EARLIER. - SECOND INCIDENT DID OCCUR RECENTLY ON FRIDAY, FEBRUARY 27. - IT INVOLVED POSIFLUSH SP 10ML SYRINGES WITH LOT 5344518. - THERE IS NO PHOTO OF THE PIECE OF PLASTIC, THIS HAS NOT BEEN PRESERVED. - A NEW CONNECTOR WAS PLACED AFTER THE INCIDENTS, HOWEVER, PATIENT IS VERY WORRIED ABOUT WHETHER OTHER PARTICLES HAVE ALREADY ENTERED THE LINE. WOULD YOU PLEASE INVESTIGATE THIS COMPLAINT AND GIVE ME FEEDBACK ON IT? BVD > I WOULD LIKE TO COMPLAIN ABOUT POSIFLUSH BD 10 ML SYRINGE INCIDENTS: > WHEN RINSING A CVC LINE, I HAVE EXPERIENCED ON 2 OCCASIONS THAT A HARD TRANSPARENT PLASTIC PIECE GOT STUCK IN THE BD NEUTRACLEAR NEEDLESS CONNECTOR. > THE HARD PIECE IS THE SHAPE AND SIZE OF A SPRINKLE AND IS TRANSPARENT. > IN INCIDENT 1, THE CONNECTOR REMAINED OPEN AND BLOOD FLOWED FROM THE LINE .... ( REPORTED TO THE EMERGENCY ROOM AMC) > IN INCIDENT 2, ABOUT 8 ML OF AIR ENTERED THE LINE THAT I MANAGED TO GET OUT MYSELF. > I CHECKED THE SYRINGE CAREFULLY BEFORE FLUSHING BUT COULD NOT SEE ANYTHING > STRANGE ABOUT IT, ONLY AFTER THE POSIFLUSH WAS UNSCREWED FROM THE CONNECTOR DID THE PIECE OF PLASTIC BECOME VISIBLE.