Catalog Number 300865 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported while using bd plastipak¿ syringes there were air bubbles in the syringe.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: air bubbles were repeatedly found in the syringe when used with an electric syringe pump.
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Manufacturer Narrative
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H.6.Investigation summary: no photos or physical samples that display the reported condition were available for investigation therefore we could not verify the reported issue.A device history review was performed for the reported lot 2206097, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Bubbles can be seen if there is damage to the syringe barrel.Ten retained samples of lot 2206097 were used for additional evaluation.The product was visually inspected, no defects or damage was observed within any of the products.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to determine a root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
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Event Description
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It was reported while using bd plastipak¿ syringes there were air bubbles in the syringe.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: air bubbles were repeatedly found in the syringe when used with an electric syringe pump.
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Search Alerts/Recalls
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