Model Number 381812 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter was found damaged in the packaging before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "upon opening the package, it was identified that the catheter is folded and torn leaving the needle more exposed.".
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter was found damaged in the packaging before use.The following information was provided by the initial reporter, translated from portuguese to english: "upon opening the package, it was identified that the catheter is folded and torn leaving the needle more exposed.".
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Manufacturer Narrative
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H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Search Alerts/Recalls
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