BD SYRINGE 5ML SALINE FILL CHINA SP

Additional Manufacturer Narrative

INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

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

IT WAS REPORTED THAT THE BD SYRINGE 5ML SALINE FILL CHINA SP CAP FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED AS A PRETERM INFANT AT 33+3 WEEKS GESTATION FOLLOWING 30 MINUTES OF RESUSCITATION AFTER BIRTH ASPHYXIA. UPON ADMISSION, THE PATIENT EXHIBITED SLIGHTLY RAPID BREATHING. ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOTRACHEAL INTUBATION IN THE OPERATING ROOM AND WAS TRANSFERRED TO OUR DEPARTMENT. POST-ADMISSION MANAGEMENT INCLUDED POSITIVE PRESSURE VENTILATION, ESTABLISHMENT OF VENOUS ACCESS, AND RADIANT WARMER THERAPY. THE PATIENT'S VITAL SIGNS ARE CURRENTLY STABLE. THIS MORNING DURING FLUID ADMINISTRATION, IT WAS DISCOVERED THAT THE PRIMING SYRINGE HAD SEPARATED FROM THE CONNECTOR CAP, FAILING TO MEET ASEPTIC REQUIREMENTS. THE NON-COMPLIANT DEVICE WAS RETAINED, AND A REPLACEMENT PRIMING SYRINGE WAS ADMINISTERED TO THE PATIENT. NO RECURRENCE OF THE AFOREMENTIONED ISSUE OCCURRED, AND NO HARM WAS CAUSED TO THE PATIENT.