Catalog Number 590500 |
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 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter zip: (b)(6).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 iv set an126 w/o pump t-type had foreign matter.The following information was provided by the initial reporter: "foreign material in drip chamber".
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Manufacturer Narrative
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H6: investigation summary in response to the event reported by the facility a device history review was conducted for lot number 2105181.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.Additionally, a sample was provided to aid in our investigation.Additionally compositional testing of the foreign material determined that the foreign material was composed of polyester.A review of the manufacturing materials allowed outr engineers to a identify the source of the foreign object as the pvc runner on the chamber injection mold machine.To prevent future occurrences of this event we have issued a retraining of our manufacturing and inspection teams.
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Event Description
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It was reported iv set an126 w/o pump t-type had foreign matter.The following information was provided by the initial reporter: "foreign material in drip chamber".
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Search Alerts/Recalls
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