DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER?S INDICATED FAILURES. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.
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Patient 1
IT WAS REPORTED THAT OVER 10 DAYS OF USE THE MARKINGS ON A SYRINGE ORAL 10ML CLEAR CAME OFF. CUSTOMER STATED, "COMPLAINT THAT I EXPERIENCED RECENTLY AS MY SON WAS TAKING ANTIBIOTICS AND WE WERE USING THE 10ML ORAL BD SYRINGE TO DRAW UP THE LIQUID. OVER THE COURSE OF THE 10 DAY ANTIBIOTIC USE WE WERE ONLY WASHING THE SYRINGE WITH REGULAR DISH SOAP BETWEEN USES. BY THE MID-WAY THROUGH THE PRESCRIPTION ALMOST ALL OF THE MARKINGS HAD COME OFF THE SYRINGE SO THAT WE WERE GUESSING ON WHERE THE 10ML LINE APPEARED."