Model Number 515056 |
Device Problems
Leak/Splash (1354); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2022 |
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 while using a bd phaseal¿ optima injector n40-o, injector separated and leakage occurred.The following information was provided by the initial reporter: i saw fluid on the ground and realized the female phaseal connecter (n35-o) on the keytruda secondary tubing was no longer connected to the secondary tubing.
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Event Description
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It was reported that while using a bd phaseal¿ optima injector n40-o, injector separated and leakage occurred.The following information was provided by the initial reporter: i saw fluid on the ground and realized the female phaseal connecter (n35-o) on the keytruda secondary tubing was no longer connected to the secondary tubing.
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Manufacturer Narrative
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H.6.Investigation: no physical samples that display the reported condition were provided for investigation.One photo of the injector was received.Through visual inspection, no damage or defects can be observed on the optima injector or luer threading that may have lead to the reported disconnection.A device history review was performed for lot 2105302, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Dimensional testing was performed, including the luer thread, verifying all critical dimensions are within specification.Product undergoes a series of visual and functional evaluations throughout the manufacturing process.Records were reviewed for the reported lot and no issues related to this failure were identified.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
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Search Alerts/Recalls
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