Model Number H74939240035131 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the device sterility was compromised.A rubicon¿ 35 was selected for use.During unpacking, it was noted that there was a short hair strand inside the sterile packaging of the device.The product was not used in any procedure.No patient complications were reported and the patient's condition was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Returned device consisted of a rubicon 35 support catheter in the sterile unopened pouch.The device sterile pouch was visually inspected for any damage or irregularities.No damage was noticed on the packaging.Visual analysis did not show any foreign matter through the pouch as returned.The pouch was opened to inspect the contents where a hair was noticed on the sterile pouch material.The quality engineer was notified and viewed the product and confirmed the foreign matter inside the pouch.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).
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Event Description
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It was reported that the device sterility was compromised.A rubicon¿ 35 was selected for use.During unpacking, it was noted that there was a short hair strand inside the sterile packaging of the device.The product was not used in any procedure.No patient complications were reported and the patient's condition was stable.
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Search Alerts/Recalls
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