UMBILICAL CORD CLAMP, 100/CS, UMBILICAL CORD CLAMP, 100/CS

Description of Event or Problem

A DEROYAL UMBILICAL CORD CLAMP WAS PLACED ON AN INFANT. THE NURSE HEARD A NOISE THAT SOUNDED LIKE THE BABY PASSING GAS, BUT UPON INVESTIGATION REALIZED THAT THE CORD CLAMP HAD POPPED OPEN. WHEN REPORTED HER COWORKERS HAD VOICED THAT THIS HAD HAPPENED PREVIOUSLY, ESPECIALLY WITH HEALTHY THICK CORDS, THAT THE CLAMP WILL NOT STAY CLOSED - WHICH IS CONCERNING AS AN INFANT COULD BLEED OUT FORM AN OPEN CORD.

Additional Manufacturer Narrative

A USER FACILITY REPORTED ON (B)(6) 2023, THAT "A DEROYAL UMBILICAL CORD CLAMP WAS PLACED ON AN INFANT. THE NURSE HEARD A NOISE THAT SOUNDED LIKE THE BABY PASSING GAS, BUT UPON INVESTIGATION REALIZED THAT THE CORD CLAMP HAD POPPED OPEN. WHEN REPORTED HER COWORKERS HAD VOICED THAT THIS HAD HAPPENED PREVIOUSLY, ESPECIALLY WITH HEALTHY THICK CORDS, THAT THE CLAMP WILL NOT STAY CLOSED - WHICH IS CONCERNING AS AN INFANT COULD BLEED OUT FORM AN OPEN CORD." THIS EVENT WAS ALSO REPORTED IN A MEDWATCH #MW5118129. DEROYAL INDUSTRIES REQUESTED THE SAMPLE, BUT IT WAS NOT ABLE TO BE RETURNED. DEROYAL REVIEWED WORK ORDERS, LABELS, AND FAILURE MODES AND EFFECTS ANALYSIS (FMEA) AND FOUND NO ISSUES. DEVICE HISTORY RECORDS WERE REVIEWED FOR LOTS 56775868, 56171010, AND 57040337. FOR EACH LOT, THE QUALITY CONTROL SPECIALIST WAS REQUIRED TO PULL 128 PARTS FROM EACH CASE OF PRODUCT PRODUCED AND SNAP THE UMBILICAL CORD CLAMP CLOSED. ALL RESULTS WERE PASSING. EVERY 3 HOURS, OPERATORS WERE REQUIRED TO VISUALLY INSPECT 8 PARTS AGAINST THE MANUFACTURING SPECIFICATION. ALL VISUAL RESULTS WERE ACCEPTABLE. AT THE BEGINNING OF THE MOLD RUN AND END OF THE MOLD RUN, A PRESSURE TEST IS REQUIRED. PRESSURE TESTING YIELDED ACCEPTABLE RESULTS. IN ADDITION, THE QUALITY CONTROL SPECIALIST PERFORMED A TIGHTENED INSPECTION THAT CONSISTS OF CHECKING EACH CASE, ONCE COMPLETE, FOR SHORT SHOTS. EACH CASE WAS INSPECTED WITH NO SHORT SHOTS FOUND. A SHIPPING AND HANDLING ERROR WAS RULED OUT AS THIS WOULD LIKELY RESULT IN ADDITIONAL PRODUCTS WITHIN THE PACK EXHIBITING A DEFORMITY. A STORAGE ERROR WAS ALSO RULED OUT AS THIS WOULD LIKELY NOT HAVE IMPACTED THE PRODUCT IN THIS MANNER UNLESS DAMAGE OCCURRED. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT RETURNED, THE TRUE ROOT CAUSE COULD NOT BE IDENTIFIED. POTENTIAL ROOT CAUSES THAT COULD NOT BE ELIMINATED ARE A MANUFACTURING ERROR (POTENTIALLY A NON-FULLY FILLED PART) OR CLINICIAN ERROR IN APPLYING THE UMBILICAL CORD CLAMP. CORRECTIVE AND PREVENTIVE ACTION: DUE TO THE INABILITY TO DETERMINE THE TRUE ROOT CAUSE, A CORRECTIVE ACTION COULD NOT BE IDENTIFIED. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS SURROUNDING THIS ITEM AND ISSUE. (B)(4). THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.