Model Number 324912 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Injury (2348)
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Event Date 03/05/2020 |
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 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 an unspecified number of syringes 1.0ml 31ga 6mm experienced difficult plunger rod movement during use.The following information was provided by the initial reporter: material no: 324912 batch no: 9140729.Verbatim: consumer reported plungers are hard to press down during injection consumer reported of the plunger that are hard to move, bends the needle and 1 time resulted in scratching her skin.Consumer reported the site is fine.Date of event: unknown.
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Manufacturer Narrative
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H.6.Investigation summary customer returned (2) loose 1cc syringes.Customer states that it is too hard for her to press down during injection, adding that that sometimes the needle bent and one time it resulted in scratching her skin.Both returned syringes were examined and one sample exhibited a bent cannula.Both samples were also tested and both were able to draw and expel properly.A review of the device history record was completed for batch# 9140729.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion bd was able to duplicate or confirm the customer¿s indicated failure (bent cannula).Bd was not able to duplicate or confirm the customer¿s indicated failure (plunger difficult to move).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.Root cause description bending of the cannula during original removal of the shielding.If the shield is not removed evenly and in roughly the opposite direction of the force applied, the cannula is easily bent by the shield flange as the shield is removed.To the consumer, this would appear as though the cannula was bent to begin with.Additionally, this type of incident does not usually leave evidence on the interior of the shield.Rationale based on the investigation, no additional investigation and no capa is required at this time.
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Event Description
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It was reported that an unspecified number of syringes 1.0ml 31ga 6mm experienced difficult plunger rod movement during use.The following information was provided by the initial reporter: material no: 324912 , batch no: 9140729.Consumer reported plungers are hard to press down during injection consumer reported of the plunger that are hard to move, bends the needle and 1 time resulted in scratching her skin.Consumer reported the site is fine date of event: unknown.
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Search Alerts/Recalls
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