NIAGARA

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE COMPLAINT OF A FOREIGN MATERIAL PRESENCE WAS CONFIRMED BUT THE ROOT CAUSE COULD NOT BE DETERMINED. ONE PHOTOGRAPH WAS RETURNED FOR EVALUATION. INSPECTION OF THE PHOTOGRAPH FOUND THAT A CYLINDRICAL MATERIAL WHICH WAS SLIGHTLY BOWED WAS PRESENT. THE FOREIGN MATERIAL WAS SITTING ATOP A SURFACE WITH NO OTHER COMPONENTS OF THE REPORTED CATHETER KIT VISIBLE IN THE PHOTO, MAKING IT DIFFICULT TO ASSESS HOW THE FOREIGN MATERIAL RELATED TO THE REPORTED KIT. THE MATERIAL HAD A WHITE/TRANSLUCENT COLOR AND A SMOOTH SURFACE TEXTURE. THE FEATURES OF THE MATERIAL SUGGESTED THAT IT WAS SOME TYPE OF PLASTIC. BASED ON THE AVAILABLE EVIDENCE, INSUFFICIENT DETAILS WERE GATHERED TO DETERMINE WHEN AND WHERE THE FOREIGN MATERIAL WAS INTRODUCED. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

Description of Event or Problem

IT WAS REPORTED PIECE OF PLASTIC PRESENT IN A LUMEN. THE FRAGMENT WAS IDENTIFIED AFTER ASPIRATION ON THE ARTERIAL LUMEN. THERE WAS AN ISSUE WITH ASPIRATION IN FIRST INSTANCE. WHEN PERSISTING A PIECE OF PLASTIC (THE FRAGMENT) WAS ASPIRATED IN THE SYRINGE. IT WAS DISCOVERED AFTER PLACING THE CATHETER IN THE VEIN. UPON PREPARATION THERE WAS NO APPARENT PROBLEM WITH THE CATHETER. THERE WAS NO CLEAR IMPACT ON THE PATIENT, AN X-RAY WAS DONE TO IDENTIFY ANY OTHER FRAGMENTS, OF WHICH NONE WAS APPARENT. THERE WAS NO CLINICAL IMPACT FOR THE PATIENT.