Catalog Number 301073 |
Device Problems
Break (1069); Failure to Align (2522); Contamination /Decontamination Problem (2895); Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2019 |
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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8154742, medical device expiration date: 2023-05-31, device manufacture date: 2018-06-03; medical device lot #: 8240729, medical device expiration date: 2023-08-31, device manufacture date: 2018-08-28.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 a bd luer-lok¿ 3ml syringe had: particulate/contamination (fm), damage, inclusions, print (scale marking issues), misaligned gasket (stopper jammed).
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Manufacturer Narrative
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Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Event Description
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It was reported that a bd luer-lok¿ 3ml syringe had : particulate/contamination (fm), damage, inclusions, print (scale marking issues), misaligned gasket (stopper jammed).
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Search Alerts/Recalls
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