Catalog Number 320550 |
Device Problem
Defective Component (2292)
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Patient Problem
Easy Bruising (4558)
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Event Date 10/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 the bd nano¿ 2nd gen pen needle was difficult to operate during use.The following information was provided by the initial reporter: "consumer reported that the patient end needle bends during injection.Consumer also reported that the pen jams during injection.Also reported that the needle slipped once as she was injecting and bruised her skin.Consumer does not re-use.".
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Event Description
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It was reported that the bd nano¿ 2nd gen pen needle was difficult to operate during use.The following information was provided by the initial reporter: "consumer reported that the patient end needle bends during injection.Consumer also reported that the pen jams during injection.Also reported that the needle slipped once as she was injecting and bruised her skin.Consumer does not re-use.".
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Manufacturer Narrative
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The following fields have been updated due to additional information: h.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.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 situational analysis (sa) is required at this time.H3 other text : see h.10.
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Search Alerts/Recalls
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