Description of Event or Problem · 1
AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY (REF: SAMM051-03 VAGINAL DELIVERY TRAY) THAT INCLUDES THE FOLLOWING COMPONENT: FORCEP, ROCH-PEAN 7.25 CURV, VENDOR REF: 12-201 SUPPLIED BY FINE SURGICAL INSTRUMENTS. THE MANUFACTURER OF THE DEVICE IS CROWN SURGICAL CORP (REG: (B)(4)). AVID MEDICAL RECEIVED A COMPLAINT ON 01/06/2020 ORIGINATED BY (B)(6), DO MC, USA MEDICAL DIRECTOR, NEWBORN NURSERY AT (B)(6) MEDICAL CENTER ((B)(6)). COMPLAINT STATES THAT A SHORT TIME AFTER THE MEDICAL STAFF APPLIED THE CLAMP TO THE PATIENT'S UMBILICAL CORD, THEY NOTICED THE PATIENT BLEEDING AND NOTED THE CLAMP HAD BROKEN. THE PHYSICIAN HELD PRESSURE TO HALT THE BLEEDING AND A PLASTIC CLAMP WAS APPLIED. NO HARM WAS REPORTED BY THE HOSPITAL FOR THIS PATIENT. THE COMPLAINED FORCEP, ROCH-PEAN 7.25 CURV PART WAS NOT AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE SUPPLIER FINE SURGICAL INSTRUMENTS. MANUFACTURER LOT# P729028. MORE DETAILS AS STATED BY HOSPITAL STAFF: CUSTOMER REPORTED, "THE PATIENT INVOLVED IS (CURRENTLY ADMITTED TO NICU). THE CHILD WAS DELIVERED VIA VACUUM-ASSISTED VAGINAL DELIVERY. UPON DELIVERY THE NEONATE WAS STUNNED, SO WAS BROUGHT OVER TO THE WARMER BY DR. (B)(6). WHEN THE CHILD ARRIVED AT THE WARMER, WE REALIZED THAT THE CLAMP ATTACHED TO THE BABY'S UMBILICAL CORD WAS BROKEN, AND THE CHILD WAS RAPIDLY BLEEDING. DR (B)(6) HELD MANUAL PRESSURE AND OUR NICU RN QUICKLY APPLIED THE PLASTIC UMBILICAL CLAMP. HOSPITAL REPORTS NO SERIOUS INJURY OR ILLNESS FROM THIS EVENT."