SPONGE: SPECIALTY PEANUT XR 100/C

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS EVENT IS AVAILABLE BUT HAS NOT BEEN RETURNED. THE COMPLAINT SPONGE: SPECIALTY PEANUT XR 100/CS PART NUMBER 7103 IS MANUFACTURED BY CARWILD CORPORATION (FDA REGISTRATION 1219313). A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE SUPPLIER. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

THE CLINICIAN ALLEGED THAT PRODUCT WAS UNRAVELING DURING USE AND LEAVING PIECES OF THE GAUZE/LINT. THE INCIDENT OCCURRED DURING A SURGICAL PROCEDURE WHERE SMALL PIECES OF COTTON NEEDED TO BE MANUALLY RETRIEVED FROM THE SURGICAL WOUND. THIS OCCURRED DURING THYROIDECTOMY WITH DISSECTION PROCEDURE. ALL LINT WAS REMOVED WITH NO ADDITIONAL TREATMENT REQUIRED.

Additional Manufacturer Narrative

THE LOT NUMBER FIELD HAS BEEN UPDATED TOO UNKNOWN. THE COMPLAINT LOT NUMBER FROM INCIDENT IS UNKNOWN. THE CUSTOMER DID LOCATE A PACK OF LOT 295972 THAT APPEARS TO HAVE SOME UNRAVELING OBSERVED. THE CUSTOMER SUBMITTED PHOTOS CONFIRMING LOOSE THREADS. SAMPLES FROM AN ADDITIONAL LOT WERE PROVIDED BY CUSTOMER AND REVIEWED. THOSE SAMPLES WERE CONFORMING WITH PRODUCT SPECIFICATIONS, NO SIMILAR UNRAVELING OR LOOSE THREADING WAS OBSERVED. MEDICAL ACTION INDUSTRIES REVIEWED THE DEVICE HISTORY RECORD FOR REPACKAGED SPONGE LOT 295972. THERE WERE NO ISSUES DETECTED; INSPECTIONS WERE CONFORMING. NO DEVIATIONS OR REWORK REPORTED. A THREE-YEAR REVIEW OF COMPLAINT RECORDS WAS REVIEWED, THERE WERE NO SIMILAR COMPLAINTS FOR THE PRODUCT WITHIN THAT TIME PERIOD. MANUFACTURER PROVIDED A SUPPLIER CORRECTIVE ACTION REPORT ON THE SPONGES. THEIR INVESTIGATION WAS LIMITED DUE TO LACK OF CLARITY ON THE INCIDENT LOT NUMBER FOR SPONGES. THE SUPPLIER HAS CONFIRMED THERE HAVE BEEN NO CHANGES TO THE MANUFACTURING PROCESS FOR SPONGES, MACHINE PREVENTIVE MAINTENANCE WAS CONFIRMED UP TO DATE, ALL ASSEMBLER TRAINING WAS UP TO DATE, AND THEY DID NOT FIND SIMILAR INCIDENTS REPORTED ON PRODUCT. THEY WERE UNABLE TO PROVIDE A ROOT CAUSE. COMPLAINTS WILL CONTINUE TO BE TRACKED AND TRENDED TO DETERMINE IF CORRECTIVE ACTIONS ARE WARRANTED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.