UMBILICAL CORD CLAMP

Additional Manufacturer Narrative

ROOT CAUSE: A ROOT CAUSE COULD NOT BE DETERMINED. A VALID LOT NUMBER WAS NOT PROVIDED FOR THE INVESTIGATION PROCESS. THE DEFECTIVE SAMPLE WAS NOT PROVIDED FOR EVALUATION. THE SAMPLES AVAILABLE FOR EVALUATION STAYED CLOSE WITH THE EXCEPTION OF ONE CLAMP. WHEN THE CLAMP THAT FAILED TO STAY ON WAS REAPPLIED, IT STAYED CLOSE. CORRECTIVE ACTION: NONE DUE TO THE ROOT CAUSE DETERMINATION. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED FOR AN UMBILICAL CORD CLAMP (PART 6833) THAT FAILED TO STAY CLOSE DURING USE. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE LOT NUMBER INITIALLY PROVIDED WAS NOT VALID. FOLLOW UP WAS PERFORMED TO OBTAIN A VALID LOT NUMBER, BUT THE INFORMATION WAS NOT ABLE TO BE OBTAINED. BECAUSE A VALID LOT COULD NOT BE OBTAINED, THE COMPLAINT INVESTIGATOR WAS UNABLE TO CHECK THE DEVICE HISTORY RECORD. TWENTY DEVICES OF A LOT ON HAND WERE CLAMPED ONTO A PIECE OF NEOPRENE FOAM. THE CLAMPS WERE CLICKED SHUT AS INDICATED IN THE INSTRUCTIONS FOR USE. ONE CLAMP POPPED OPEN. UPON FURTHER EVALUATION OF THIS CLAMP, FLASH WAS DISCOVERED IN THE LATCH AREA. THE AMOUNT OF FLASH WAS IN TOLERANCE ACCORDING TO THE MANUFACTURING SPECIFICATION. THIS CLAMP WAS REAPPLIED TO THE NEOPRENE FOAM AND LEFT FOR 24 HOURS. THIS TIME IT DID NOT POP OFF AND STAYED APPLIED TO THE FOAM FOR THE FULL 24 HOURS. SINCE (B)(6) 2018, (B)(4) UNITS HAVE BEEN SOLD. DURING THIS TIMEFRAME, THERE HAVE BEEN TWO COMPLAINTS, YIELDING A COMPLAINT-TO-SALES RATIO OF (B)(4). THERE HAS BEEN ONE OTHER LIKE COMPLAINT REPORTED DURING THIS TIMEFRAME. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

PHYSICIANS HAVE COMPLAINED THAT THE CLAMP ISN'T STURDY ENOUGH TO HOLD WHEN PLACED ON THE UMBILICAL CORD, WHICH IS CAUSING THE CLAMP TO POP OFF.