Catalog Number AK-05502 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that the clinician noticed before opening that the blue plastic corner of the kit peeled back, causing the kit to lose integrity and could not be used.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the outer tray and kit with no relevant findings.Visual inspection could not be performed as no sample was returned by the customer for investigation.The customer provided a photo; however, the photo could not confirm the complaint.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.The customer did provide a photo; however, the photo could not confirm the complaint.A device history record review was performed on the outer tray and kit with no evidence to suggest a manufacturing related cause.The potential cause of the tray corner of the kit being peeled back prior to use could not be determined based upon the information provided and without a sample.
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Event Description
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It was reported that the clinician noticed before opening that the blue plastic corner of the kit peeled back, causing the kit to lose integrity and could not be used.
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Search Alerts/Recalls
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