Catalog Number 383715 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (b)(6).H3.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 pegasus¿ safety closed iv catheter system was missing the diaphragm.The following was translated from chinese to english: when ready to use, upon opening the package, it was found that the product did not have a heparin cap.
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Manufacturer Narrative
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H6: investigation summary a device history review was conducted for lot number 2335073.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that the bd pegasus¿ safety closed iv catheter system was missing the diaphragm.The following was translated from chinese to english: when ready to use, upon opening the package, it was found that the product did not have a heparin cap.
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Search Alerts/Recalls
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