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Additional Manufacturer Narrative

THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. THE DEVICE WAS RETURNED IN ITS ORIGINAL PACKAGING. THE OUTER BOX DID NOT APPEAR TO HAVE ANY DAMAGE WHICH WOULD INDICATE MISHANDLING. UPON OPENING THE OUTER BOX, THE INNER TYVEK POUCH WAS FOUND TO BE UNSEALED AT THE CHEVRON. THE SEAL WAS OTHERWISE INTACT AROUND THE PACKAGING. THE TYVEK POUCH WAS NOT TORN OR PUNCTURED. THE PACKAGING HAD BEEN PEELED OPEN AT THE SEAL AND THE RESIDUE ON THE MYLAR LOOKED LIKE THE SEAL WAS AT ONE POINT CONTIGUOUS. BASED ON THE RESULT OF THE INVESTIGATION, IT IS UNKNOWN AT WHAT POINT THE TYVEK POUCH WAS BREACHED. AS SEAL INTEGRITY IS VERIFIED AT EACH STATION PRIOR TO SECONDARY PACKAGING, WHERE THE DEVICE IS PACKAGED IN THE OUTER BOX, IT IS UNLIKELY THE BREACH OCCURRED PRIOR TO RELEASE FROM STRYKER. THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE SHOWS THAT THE DEVICE PASSED ALL INSPECTION PRIOR TO SHIPMENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE INNER PACKAGE OF THE DIAGNOSTIC ULTRASOUND CATHETER WAS OPENED WHEN IT WAS HANDED TO THE SCRUB TECH.