Catalog Number 386804 |
Device Problem
Structural Problem (2506)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 02/26/2019 |
Event Type
Injury
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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.
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Event Description
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It was reported that when using a bd cathena¿ safety iv catheter there was a needle stick.The following was reported, " paramedic contacted me via text message on sunday, march 3rd to report two pirs.Conveyed that the first incident involved mr.Xxxx, using a 20g cathena resulted in a needle stick due to "structural failure of the device." first incident the clear blood piece came free resulting in a needle stick.Sample was placed in a bio-hazardous bag but then accidentally thrown out.Will meet in person so gather additional info.Per customer information response: can you please explain what you mean by ¿structural failure device¿? technique related, (b)(6) said ¿structural failure because he is was brought to our attention most of the er staff were ¿breaking¿ the needle.Did the needle stick occurr before, during or after use?- during use.Was there medical intervention? unknown.Exposure to blood/bodily fluid?-unknown.Are samples available for evaluation? no".
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Manufacturer Narrative
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Describe event or problem: it was reported that when using a bd cathena¿ safety iv catheter there was a needle stick.The following was reported, paramedic contacted me via text message on sunday, march 3rd to report two pirs.Conveyed that that the first incident, using a 20g cathena resulted in a needle stick due to "structural failure of the device." first incident the clear blood piece came free resulting in a needle stick.Sample was placed in a bio-hazardous bag but then accidentally thrown out.Will meet in person so gather additional info.Per customer information response: can you please explain what you mean by ¿structural failure device¿?- technique related, said ¿structural failure because he is was brought to our attention most of the er staff were ¿breaking¿ the needle did the needle stick occurr before, during or after use?- during use was there medical intervention?- unknown.Exposure to blood/bodily fluid?-unknown.Are samples available for evaluation?- no.Investigation summary: no samples and photo were returned for investigation.A review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.No abnormality was observed during the production of the reported batch.The investigation was not able to confirm the what customer had experienced as no samples and no photos were received for evaluation.Hence, root cause is unable to be determined.
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Event Description
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It was reported that when using a bd cathena¿ safety iv catheter there was a needle stick.The following was reported, paramedic contacted me via text message on sunday, march 3rd to report two pirs.Conveyed that that the first incident, using a 20g cathena resulted in a needle stick due to "structural failure of the device." first incident the clear blood piece came free resulting in a needle stick.Sample was placed in a bio-hazardous bag but then accidentally thrown out.Will meet in person so gather additional info.Per customer information response: can you please explain what you mean by ¿structural failure device¿?- technique related, said ¿structural failure because he is was brought to our attention most of the er staff were ¿breaking¿ the needle did the needle stick occurr before, during or after use?- during use was there medical intervention?- unknown.Exposure to blood/bodily fluid?-unknown.Are samples available for evaluation?- no.
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Search Alerts/Recalls
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