Catalog Number 385110 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that prn luer slip adapter.75in inj site shield detached.This was discovered before use.The following information was provided by the initial reporter: the shield on the product tip was detached.
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Manufacturer Narrative
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H.6 investigation summary: a device history review was conducted for lot number 9196787.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Based on the photograph submitted by the facility, our engineers were able to determine that the loose cap was caused by an error in the manual attachment of the heparin cap to the adapter.To address this issue we have retrained the appropriate personnel.
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Event Description
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It was reported that prn luer slip adapter.75in inj site shield detached.This was discovered before use.The following information was provided by the initial reporter: the shield on the product tip was detached.
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Search Alerts/Recalls
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