Model Number 309657 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/29/2019 |
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.
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Event Description
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It was reported that during use foreign matter was discovered in syringe with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter: it was reported that a syringe was filled with insulin and a white stringy substance appeared to be floating around in it.Number of occurrences: 1.Did the customer insert the needle into the cartridge and encounter fill resistance? no.Proceed to step 4.Item number: 3 ml syringe 309657, product lot number: 8297827.For bd product only, are samples available for investigation? no.Did issue cause any injury? if yes, what type of injury? no.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? n/a.
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Manufacturer Narrative
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The following field has been updated with corrected information: h.4.Device manufacture date: 2018-12-14 h3 other text : see h.10.
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Event Description
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It was reported that during use foreign matter was discovered in syringe with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter: it was reported that a syringe was filled with insulin and a white stringy substance appeared to be floating around in it.Number of occurrences: did the customer insert the needle into the cartridge and encounter fill resistance? no.Proceed to step 4.Item number 3 ml syringe ¿ 309657.Product lot number: 8297827.For bd product only, are samples available for investigation? no.Did issue cause any injury? if yes, what type of injury? no.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? n/a.
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Event Description
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It was reported that during use foreign matter was discovered in syringe with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter: it was reported that a syringe was filled with insulin and a white stringy substance appeared to be floating around in it.2.Number of occurrences: 1 3.Did the customer insert the needle into the cartridge and encounter fill resistance? o no.Proceed to step 4.4.Item number 3 ml syringe ¿ 309657 5.Product lot number: 8297827 6.For bd product only, are samples available for investigation? o no.7.Did issue cause any injury? if yes, what type of injury? no.8.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? n/a.
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Manufacturer Narrative
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H.6.Investigation summary : 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
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Search Alerts/Recalls
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