DRAINAGE BAG CONNECTOR CONNECTING TUBE

Additional Manufacturer Narrative

CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2024 INDICATING THAT THE DEVICE SEPARATED AT THE FUNNEL END, AND DID NOT SEPARATE AT THE STOPCOCK. THERE IS NO EVIDENCE TO SUGGEST THAT THE OBSERVED DEVICE FAILURE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF THE FAILURE WERE TO RECUR. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, AS NO LIFE-THREATENING OR PERMANENTLY IMPAIRING INJURY TOOK PLACE, NOR WAS INTERVENTION TAKEN AS A RESULT OF THE DEVICE FAILURE WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. THE NEPHROSTOMY CATHETER DID NOT REQUIRE REPLACEMENT. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H10.

Additional Manufacturer Narrative

G2 - REPORT SOURCE - OTHER: COMPETENT AUTHORITY, MHRA.G4 - PMA/510(K) #: EXEMPT.THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

IT WAS REPORTED THAT THE DRAINAGE BAG CONNECTOR CONNECTING TUBE BROKE AWAY FROM THE CONNECTOR THAT ATTACHED TO THE URINE BAG OF AN UNKNOWN PATIENT. FOLLOWING PLACEMENT INTO THE PATIENT DURING A NEPHROSTOMY EXCHANGE, DRAINAGE WAS DETERMINED TO BE FINE, AND THE PATIENT WAS SENT HOME. WHILE AT HOME, THE PATIENT NOTICED A WET PATCH AND FOUND THAT THE TUBES HAD COME APART. THE PATIENT THEN RETURNED TO THE HOSPITAL TO HAVE THE CONNECTING TUBE AND DRAINAGE BAG CHANGED. ONCE REMOVED, IT WAS FOUND THAT THE CONNECTOR HUB HAD COME APART FROM THE TUBE.THE PATIENT NOTED THAT THEY DID NOT REMEMBER PULLING ON THE TUBE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.