ORS-188231 WARMER DRAPE WITH SKIRT

Additional Manufacturer Narrative

(B)(4) PACKAGED DRAPES ALONG WITH THE DRAPE WITH THE REPORTED SLITS WERE RETURNED. AFTER EXAMINING THE RETURNED DEVICE, TWO SMALL SLITS WERE OBSERVED. THE DEVICE WAS RETURNED TO THE MANUFACTURING PLANT FOR FURTHER INVESTIGATION. THE DHR WAS REVIEWED AND NO DEFECTS WERE REPORTED REGARDING THE PROCESS, PACKAGING, OR FINAL INSPECTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED. FOLLOW UP #1: DURING THE REVIEW OF THE SAMPLE RECEIVED, IT WAS CONFIRMED THAT THE FAILURE MODE WAS "WORK IN PROCESS" MIXED. THE FENESTRATION (SLIT) IN SAMPLE IS FOUND ON OTHER FABRICATIONS OF THE ORS DRAPE PRODUCT FAMILIES. THIS DRAPE WITH THE SLIT WAS INADVERTENTLY MIXED WITH DRAPES THAT WERE NOT INTENDED TO HAVE FENESTRATIONS PRESENT. A QUALITY ALERT WAS PLACED IN THE MANUFACTURING AREA TO SHOW THE NON CONFORMANCE TO THE OPERATORS. APPLICABLE PERSONNEL WERE TRAINED ON THE QUALITY ALERT. THE MANUFACTURING PROCEDURE WAS UPDATED AND APPLICABLE TRAINING WAS CONDUCTED.

Description of Event or Problem

IT WAS REPORTED THAT A WARMER WAS DRAPED AND WHEN THE IRRIGATION SOLUTION WAS POURED, A SLIT WAS NOTICED IN THE DRAPE. THE CUSTOMER PULLED ALL DRAPES IN THE LOT.

Additional Manufacturer Narrative

ELEVEN PACKAGED DRAPES ALONG WITH THE DRAPE WITH THE REPORTED SLITS WERE RETURNED. AFTER EXAMINING THE RETURNED DEVICE, TWO SMALL SLITS WERE OBSERVED. THE DEVICE WAS RETURNED TO THE MANUFACTURING PLANT FOR FURTHER INVESTIGATION. THE DHR WAS REVIEWED AND NO DEFECTS WERE REPORTED REGARDING THE PROCESS, PACKAGING, OR FINAL INSPECTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT A WARMER WAS DRAPED AND WHEN THE IRRIGATION SOLUTION WAS POURED, A SLIT WAS NOTICED IN THE DRAPE. THE CUSTOMER PULLED ALL DRAPES IN THE LOT.