Description of Event or Problem · 0
(B)(6) OPERATING ROOM HAVE DISCOVERED A SIGNIFICANT NUMBER OF CONTAMINATED MEDLINE INDUSTRIES, LP CUSTOM OR PACKS. THE CONTAMINATION RANGES FROM BLACK AND RED PARTICULATES, HAIR, SKIN TISSUE, PIECE OF RED PAINTED FINGERNAIL AND EYE LASHES - AMONG OTHER CONTAMINANTS. ON MAY 17TH, 2024 - MEDLINE WAS NOTIFIED OF OUR PARTICULATE QUALITY CONCERNS. SINCE THAT TIME - THE FREQUENCY OF CONTAMINATED PACKS HAS GROWN CONSIDERABLE. TO DATE - WE HAVE IDENTIFIED 182 CONTAMINATED CUSTOM OR PACKS. THIS HAS BEEN REPORTED TO THE MEDLINE. IN PREVIOUS QUARTERS - THERE WE 3-8 CONTAMINATED CUSTOM OR PACKS PER QUARTER REPORTED, COMPARED 182 CONTAMINATED CUSTOM OR PACKS REPORTED. THIS POSES A PATIENT SAFETY RISK FOR PATIENTS. THERE IS POTENTIAL FOR SURGICAL SITE INFECTIONS IF THE CONTAMINATION IS NOT IDENTIFIED WHEN THE PACK IS BEING OPENED IN THE STERILE ENVIRONMENT. THIS ALSO CAUSES A DELAY IN EMERGENT CASES AS MULTIPLES PACKS MAY NEED TO BE OPENED AND THE ENTIRE STERILE FIELD MAY NEED TO BE TAKEN DOWN. WE HAVE INCLUDED THE LOT NUMBERS FOR THE CUSTOM PACKS. REFERENCE REPORTS: MW5156579, MW5156580, MW5156581, MW5156582, MW5156583, MW5156584, MW5156585, MW5156586, MW5156587, MW5156588, MW5156589, MW5156590, MW5156591, MW5156592, MW5156593, MW5156594, MW5156595, MW5156596, MW5156597, MW5156598, MW5156599, MW5156600, MW5156601, MW5156602, MW5156604, MW5156605, MW5156606, MW5156607, MW5156608.