Model Number 382533 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2021 |
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 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 was reported that bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter had some debris on it.Customer was inspecting tip of catheter prior to insertion and noticed some debris on the tip of the catheter.The rn did not inserted the catheter but saved it.
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received three units.Upon visual inspection, it was noted that one of the needle tips had a slightly thicker layer of lubricant; however, lubricant is not considered a foreign material as it is a part of the design.No foreign material was noted on any parts of the returned units.Bd was unable to confirm the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported that bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter had some debris on it.Customer was inspecting tip of catheter prior to insertion and noticed some debris on the tip of the catheter.The rn did not inserted the catheter but saved it.
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Event Description
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It was reported that bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter had some debris on it.Verbatim: customer was inspecting tip of catheter prior to insertion and noticed some debris on the tip of the catheter.The rn did not inserted the catheter but saved it.
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Manufacturer Narrative
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The following fields have been updated with additional information: d.4.Medical device lot #: 1144503 h.4.Device manufacture date: 2021-05-24.
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Search Alerts/Recalls
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