BD BONNANO¿ CATHETER

Description of Event or Problem

IT WAS REPORTED BD BONNANO¿ CATHETER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE DR WAS PREPARING AND TESTING CATHETER AS ROUTINE PRIOR TO INSERTION AND NOTICED AN ABNORMAL RESISTANCE WHEN SLIDING NEEDLE OVER CATHETER COMPARED TO THE USUAL FEEL WITH THESE DEVICES. HE FELT IT WAS NOT APPROPRIATE TO PROCEED AND USED ANOTHER DEVICE WITHOUT THIS ISSUE."

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: AFTER EVALUATION OF PROVIDED SAMPLE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND NO DISCREPANCY OR NON-CONFORMANCE WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: BONNANO. DEVICE FAILURE: ADAPTER / CONNECTOR DAMAGED / DEFECTIVE.