Catalog Number 328512 |
Device Problems
Partial Blockage (1065); Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Event Description
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It was reported that 1 bd insulin syringe with the bd ultra fine¿needle was difficult to prime and inject.The following information was provided by the initial reporter : the consumer reported that the needle will not draw and stated that the plunger rod appeared to be blocked and bounced back while trying to draw.Date of event : unknown.Samples : available.
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Manufacturer Narrative
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Date of event: unknown.Medical device expiration date : unknown.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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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 1/6/2022 h.6.Investigation: customer returned (1) 3/10cc, 8mm, 31g syringe in an open poly bag from lot # 0160001.Customer states that the needle wiill not draw, plunger rod appeared to be blocked and bounced back while drawing.The returned syringe was tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 0160001.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.
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Event Description
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It was reported that 1 bd insulin syringe with the bd ultra fine¿needle was difficult to prime and inject.The following information was provided by the initial reporter : the consumer reported that the needle will not draw and stated that the plunger rod appeared to be blocked and bounced back while trying to draw.Date of event : unknown samples : available.
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Search Alerts/Recalls
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