Catalog Number 328418 |
Device Problem
Contamination (1120)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.Investigation summary: customer returned a photo of a cannula.Customer states that he noticed what looked like an actual piece of tissue adhering near the tip of the needle itself.The attached photo was examined and exhibited a piece of material on the cannula shaft.However, it is difficult to determine the identity of the observed fm on the cannula without the actual sample.A review of the device history record was completed for batch# 7353795.All inspections were performed per the applicable operations qc specifications.There were five (5) notifications [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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: root cause cannot be determined at this time as the identity of the fm observed on the cannula cannot be determined without the actual sample.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 before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.
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Manufacturer Narrative
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Awareness date corrected from: 16-jul-2018 corrected to: 15-jul-2018.Date received by manufacturer: 7/15/2018.
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Event Description
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It was reported that before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.
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Event Description
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It was reported that before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.
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Manufacturer Narrative
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Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other, d.8.Device single use?: no, h.3.Device returned to manufacture: no.
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Search Alerts/Recalls
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