Catalog Number 59006488 |
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.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used as a default.
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Event Description
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It was reported that syringe 10ml 21g 1-1/4in contained foreign matter.The following information was provided by the initial reporter: "foreign material in needle hub".
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Manufacturer Narrative
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D10: device available for eval yes, d10: returned to manufacturer on: 2021-09-14.Investigation summary: a device history review was conducted for lot number 1106282.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 submitted to our facility to aid in investigation.They noted the presence of a foreign material behind the needle hub.This material was gathered and submitted for compositional testing, which identified the material as polypropylene the same material as the needle hub.Our engineers were able to determine that the most likely root cause for this event is related to the manufacturing process of our supplier for this component.H3 other text : see h10.
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Event Description
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It was reported that syringe 10ml 21g 1-1/4in contained foreign matter.The following information was provided by the initial reporter: "foreign material in needle hub".
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Search Alerts/Recalls
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