Description of Event or Problem · 1
FEEDBACK FROM OUR POST-PARTUM OBSTETRICAL NURSING MANAGER THAT THE TYPENEX BRACELETS FOR MOTHERS AND THEIR NEWBORNS ARE DETERIORATING. THE PLASTIC CELLOPHANE COVERING IS PEELING OFF. A NEW MOTHER WHO WAS BREAST FEEDING BECAME VERY ALARMED WHEN A SMALL PIECE OF THE CELLOPHANE COVERING FELL ON TO HER BREAST WHILE NURSING HER NEWBORN. NO PATIENTS HAVE BEEN HARMED. THE BRACELETS ARE IN PLACE FOR 1-3 DAYS. THESE BANDS ARE USED TO IDENTIFY INDIVIDUAL PATIENTS AND TO MATCH THE CORRECT MOTHER TO THE CORRECT INFANT.1) POST-PARTUM UNIT COLLECTED 5 MORE EXAMPLES OF UNACCEPTABLE BRACELET. ALL BRACELETS WERE ON PATIENT FOR LESS THAN 3 DAYS AND DETERIORATED. ALL 5 BRACELETS WERE ESSENTIALLY ILLEGIBLE.2) THE PRODUCT CODE 4R-46-10- CONFIRMED LOT (01)892159002024(10)M081612 TYPENEX SERIES HRI AS A PROBLEMATIC LOT. THERE ARE OTHER LOTS THAT HAVE SAME PROBLEM, IN PARTICULAR LOT WITH TYPENEX SERIES HSE.======================MANUFACTURER RESPONSE FOR TYPENEX BRACELET, BARCODE BLOOD BANK BANDS FOR HANDWRITING CATALOG CODE -4R4680 YELLOW (PER SITE REPORTER).======================PER E-MAIL FROM REGIONAL ACCT MGR, "PLEASE SEND THE EFFECTED BAND SAMPLES TO THE ADDRESS BELOW INCLUDED WITH MY SIGNATURE. ONCE WE RECEIVE THE BANDS WE CAN COMPLETE TESTING AND COME UP WITH REASONS FOR WHY THIS IS HAPPENING AS WELL AS NEXT STEPS. I AM NOT AWARE OF ANY CHANGES IN MATERIAL OR PRODUCTION THAT HAVE BEEN MADE TO YOUR CURRENT BAND. IT WOULD BE HELPFUL IF YOU CAN PROVIDE LOT NUMBERS ASSOCIATED WITH THE BANDS."WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TYPENEX BRACELET.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.