CLEARLINK

Description of Event or Problem

IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET HAD HOLES IN THE TUBING, RESULTING IN LEAKAGE OF NORMAL SALINE. THE EVENT OCCURRED WHILE THE USER WAS PREPARING TO ADMINISTER A UNIT OF BLOOD. THE USER SPIKED THE NORMAL SALINE BAG AND THEN, THE BLOOD UNIT. DURING PRIMING WITH NORMAL SALINE, FLUID RAPIDLY LEAKED FROM THE TUBING ONTO THE FLOOR. UPON INSPECTION, HOLES WERE IDENTIFIED IN THE TUBING AT THE CLAMP SECTION ON BOTH THE NORMAL SALINE AND BLOOD LINES. THE USER ATTEMPTED TO SWITCH THE UNIT OF BLOOD TO A NEW TUBING; HOWEVER, WAS UNABLE TO REMOVE THE TUBING. DURING FURTHER INSPECTION, THE TUBING LOOKED ¿PERFORATED¿ AND AFTER MANIPULATION, THE TUBING RIPPED LARGER WITH A WHOLE CHUNK OF THE TUBING COMING OFF. A NEW BLOOD UNIT AND TUBING WOULD BE USED TO CONTINUE THE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4: EXPIRATION DATE (UPDATE THE NULL VALUE TO N/A), H4, H6(UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, THREE (03) PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPHS SHOWED A CUT IN THE TUBING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.