SENSICA UO MONITOR

Description of Event or Problem

IT WAS REPORTED THAT THE CELL PIN OF THE SENICA DEVICE WAS BENT. AS PER EMAIL RESPONSE ON 29MARCH2022, NURSE STATED THAT THE DEVICE WAS NOT ON A PATIENT DURING REPORTED EVENT. AT THAT TIME THE NURSE DID NOT KNOW HOW THE PIN WAS BENT. NURSE STATED THAT THE DEVICE WAS COMING IN FOR REPAIR. AS PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THE TECHNICIAN FOUND WHILE MAKING THE REPLACEMENT OF THE RUBBER FEET THAT THE BOTTOM PLASTIC HOUSING OF THE BASE WAS CRACKED, WHICH COULD CAUSE INGRESS IN A WET SITUATION, SO HE REPLACED THE BOTTOM HOUSING WHICH IS INCLUDED IN THE SUB ASSEMBLY POLE BASE. THE POLES WERE PERMANENTLY GLUED TO THE PLASTIC BASE, SO POLES HAVE TO BE REPLACED AS WELL. PER SAMPLE EVALUATION RESULTS RECEIVED ON (B)(6) 2022, IT WAS REPORTED THAT SEVERAL RUBBER FEET (RM0301264) WERE MISSING. IT WAS NOTED THAT THE RUBBER FEET THAT WERE REPLACED.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A CASCADING FAILURE OF AN EVENT PREVIOUSLY REPORTED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

Description of Event or Problem

IT WAS REPORTED THAT THE CELL PIN OF THE SENICA DEVICE WAS BENT. AS PER EMAIL RESPONSE ON 29MARCH2022, NURSE STATED THAT THE DEVICE WAS NOT ON A PATIENT DURING REPORTED EVENT. AT THAT TIME THE NURSE DID NOT KNOW HOW THE PIN WAS BENT. NURSE STATED THAT THE DEVICE WAS COMING IN FOR REPAIR. AS PER ADDITIONAL INFORMATION RECEIVED ON 21SEP2022, THE TECHNICIAN FOUND WHILE MAKING THE REPLACEMENT OF THE RUBBER FEET THAT THE BOTTOM PLASTIC HOUSING OF THE BASE WAS CRACKED, WHICH COULD CAUSE INGRESS IN A WET SITUATION, SO HE REPLACED THE BOTTOM HOUSING WHICH IS INCLUDED IN THE SUB ASSEMBLY POLE BASE. THE POLES WERE PERMANENTLY GLUED TO THE PLASTIC BASE, SO POLES HAVE TO BE REPLACED AS WELL. PER SAMPLE EVALUATION RESULTS RECEIVED ON 21SEP2022, IT WAS REPORTED THAT SEVERAL RUBBER FEET (RM0301264) WERE MISSING. IT WAS NOTED THAT THE RUBBER FEET THAT WERE REPLACED.