PER THE MEDWATCH REPORT RECEIVED 02/23/2015, THE NURSE WAS ASSESSING BABY AND IDENTIFIED BLEEDING FROM THE BABY'S RIGHT HAND, PINKY FINGER. PRIOR TO THE NURSE OBSERVING BLEEDING FINGER, THE NURSE HAD USED THE CORD CLAMP CUTTER TO REMOVE THE CORD CLAMP. THE INFANT'S HANDS WERE NOT NEAR THE CORD CLAMP CUTTER BLADE WHEN THE NURSE WAS REMOVING THE CORD CLAMP. IT IS BELIEVED THAT THE PINKY MAY HAVE COME IN CONTACT WITH THE HINGE OF THE DEVICE CAUSING THE LACERATION. PRESSURE WAS IMMEDIATELY APPLIED AND THE PHYSICIAN WAS NOTIFIED. THE WOUND WAS IRRIGATED AND DRESSED. ORTHOPEDICS CONSULTED AND CLOSED WOUND WITH HISTOACRYL. FINGER REMAINED WARM, PINK, AND NEWBORN WAS ABLE TO MOVE SPONTANEOUSLY. NEWBORN WAS DISCHARGED THE FOLLOWING AFTERNOON AS PLANNED WITH SCHEDULED FOLLOW-UP APPOINTMENT WITH THE ORTHOPEDIC PHYSICIAN.
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Patient 1
SUBMIT DATE: 3/11/2015.AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.(B)(4).
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Patient 1
SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE DEFECT AND ROOT CAUSE ANALYSIS. THE MOST PROBABLE ROOT CAUSE COULD BE MISUSE DURING HOSPITAL SUCH AS INADVERTENTLY SCRATCH TO THE FINGER. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.
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Patient 1
THE SUBMIT DATE ON THE INITIAL REPORT WAS INADVERTENTLY LISTED AS (B)(6) 2015 AND SHOULD BE (B)(6) 2015.