Catalog Number 309742 |
Device Problem
Inappropriate Audible Prompt/Feedback (2280)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/17/2020 |
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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that syringe 50ml ll clear 14ga 1-1/4in pump alarms.The following information was provided by the initial reporter: the mistake does not happen when using b.Braun syringes.The customer wants to receive new syringes.The pump shows locking alarm after 80%.Background: the syringes are filled in the pharmacy with opiates and used in the labor room.
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Event Description
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It was reported that syringe 50ml ll clear 14ga 1-1/4in pump alarms.The following information was provided by the initial reporter: the mistake does not happen when using b.Braun syringes.The customer wants to receive new syringes.The pump shows locking alarm after 80%.Background: the syringes are filled in the pharmacy with opiates and used in the labor room.
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Manufacturer Narrative
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H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 1911207, no deviations or non-conformances related to this issue were identified during the manufacturing process.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot.Testing results were reviewed for lot 1911207 and all results were found to be within required limits.Ten retained samples of lot 1911207 were used for additional evaluation.The product was visually inspected, no damaged or molding defects were observed and silicone content and breakout force testing verified product met required specifications.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.
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Search Alerts/Recalls
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