Catalog Number 382534 |
Device Problems
Device Operates Differently Than Expected (2913); Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly, leaving the needle exposed.There was no report of injury or medical interventions.
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Manufacturer Narrative
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Investigation summary: device/batch history record review: dhrs are available for review as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable.Findings: although a dhr review it required for this mdr complaint, review was not conducted because a lot number was not provided for this incident.Sap (qn) database review: no.Reason: this database tracks any issue during production that would affect product quality.Findings: subject code was an s1 severity ranking.Review was not conducted for this mdr- level a investigation, because a lot number was not provided for this incident.Analysis of peura and/or fmea conducted by qe: the peura (end user risk analysis) rm5835 rev 12 version j was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Visual analysis: observations and testing: observations and testing could not be performed because units were not received for investigation of this incident.Investigation samples(s) meet manufacturing specifications: unknown; units were not received for observation and testing.Investigation conclusion: root cause is indeterminate.Comment: units not provided for investigation of the incident stated in the pir.
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Event Description
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It was reported that the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly, leaving the needle exposed.There was no report of injury or medical interventions.
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Search Alerts/Recalls
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