Catalog Number 393237 |
Device Problems
Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 05/20/2020 |
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 during insertion of cannula it broke and had a new one had to be inserted with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter: nurse tried to insert the cannula.The cannula along with stylet broke during procedure.The nurse removed the broken part of cannula and stylet and had to initiate a new cannulation.
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Manufacturer Narrative
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H.6.Investigation: two photos were received by our quality team for evaluation.Upon visual inspection, it was observed that the needle hub has been broken, therefore the incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.As no sample was received, a full investigation could not be preformed therefore the root cause could not be determined.If a sample is received in the future, the complaint will be reopened and re-investigated.
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Event Description
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It was reported that during insertion of cannula it broke and had a new one had to be inserted with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter: nurse tried to insert the cannula.The cannula along with stylet broke during procedure.The nurse removed the broken part of cannula and stylet and had to initiate a new cannulation.
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Search Alerts/Recalls
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