Catalog Number 990147 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Hyperglycemia (1905)
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Event Date 03/21/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd plastipak¿ syringes the medication could not be delivered.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: the son of a dog's caregiver got in touch saying that he bought 40 plastipak syringes to apply insulin to his pet.On tuesday, the 21st of march, he was applying the insulin and noticed that the insulin did not completely come out of the syringe.He realized that the pet's blood glucose was still high, this whole week he tested 9 syringes and all are hard with difficulty to apply, it only releases 40% of the insulin when squeezing, informed the notifier.
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H.6.Investigation summary: no physical samples were received however the investigation was performed based on the photo(s) provided.Embecta was unable to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situation analysis (sa) is required at this time.
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Event Description
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It was reported while using bd plastipak¿ syringes the medication could not be delivered.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: the son of a dog's caregiver got in touch saying that he bought 40 plastipak syringes to apply insulin to his pet.On tuesday, the 21st of march, he was applying the insulin and noticed that the insulin did not completely come out of the syringe.He realized that the pet's blood glucose was still high, this whole week he tested 9 syringes and all are hard with difficulty to apply, it only releases 40% of the insulin when squeezing, informed the notifier.
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Search Alerts/Recalls
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