MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER?S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: CAPA IS NOT NECESSARY AT THIS TIME.
D
Patient 1
IT WAS REPORTED THAT THE BD INTEGRA? SYRINGE WITH DETACHABLE NEEDLE MADE A "POP NOISE" DURING USE AND REMAINED IN THE INJECTION SITE. THE CONSUMER WAS TAKEN TO THE ER, WHERE AN X-RAY WAS COMPLETED. A SURGEON WAS VISITED ON (B)(6) 2020, WHERE A "FLUOROSCOPE" WAS DONE, AND A "POST OPERATION CLIP FROM ANOTHER INCIDENT NON RELATED TO BD" WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARENT REPORTED MOM GAVE INJECTION TO SON THOUGHT NEEDLE BROKE OFF IN SITE. MOM HEARD A POP NOISE WHEN COMPLETED THE INJECTION AND NEEDLE WAS STILL IN SON'S SITE. MOM TOOK HER SON TO THE ER AND THEY COMPLETED AN XRAY. THEY THEN WENT TO SEE A SURGEON (B)(6) 2020 THEY COMPLETED A FLUOROSCOPE AND FOUND A POST OPERATION CLIP FROM ANOTHER INCIDENT NON RELATED TO BD. MOM CALLING BD ASKING OF THE RETRACTING TECH OF THE INTEGRA SYRINGE AND WANTS TO FIND THE NEEDLE WITHIN THE SYRINGE."