Catalog Number 320440 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Vitreous Floaters (1866); Foreign Body In Patient (2687)
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Event Date 12/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It has been reported that the bd ultra-fine¿ insulin syringe has been found containing foreign matter after use.The following has been provided by the initial reporter: it was reported that "floaters" were reported and confirmed by the physician.Verbatim: we have another diagnosed case of silicone oil bubbles post injection.Patient had a right eye injection (b)(6) 2019."floaters" were reported and confirmed by dr.Yesterday, (b)(6) 2019.We will be seeing him again in feb 2020 for ongoing treatment.
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Event Description
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It has been reported that the bd ultra-fine¿ insulin syringe has been found containing foreign matter after use.The following has been provided by the initial reporter: it was reported that "floaters" were reported and confirmed by the physician.We have another diagnosed case of silicone oil bubbles post injection.Patient had a right eye injection on (b)(6) 2019."floaters" were reported and confirmed by dr.Yesterday, on (b)(6) 2019.We will be seeing him again on (b)(6) 2020 for ongoing treatment.
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Manufacturer Narrative
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H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.It is important to note bd only markets insulin delivery syringes for subcutaneous use.Consistent with the naming convention and scale marking of an insulin syringe, it is insulin-specific, and it is approved by health canada for the intended use of subcutaneous injection of insulin.Insulin scale mark gradations are in insulin units as opposed to ml found on general purpose syringes.Bd does not intend for its insulin syringes to be used for any purpose other than subcutaneous injection of insulin.A review of the device history record was completed for batch#: 9014703.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for silicone outer diameter of barrel.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.
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Search Alerts/Recalls
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