Catalog Number UNKNOWN |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the unspecified bd¿ infusion set tubing was expanded/bulged.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "two separate iv tubing reports.Rn noted the soft part of iv tubing has a bulge.".
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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: 8/30/2021.H.6.Investigation: one sample and one photo were returned by the customer.It was reported iv tubing has a bulge.The photo shows two incomplete tubing sets that appear to have a bulge/bubble in their pumping segments.The customer complaint can be verified.The returned sample was examined for defects and abnormalities.The returned sample is not a complete set.The portion of tubing that was returned is from the back check valve to the second smartsite.Therefore, an infusion could not be completed and accurate model and lot numbers could not be identified.A device history record review could not be performed because a model number was not provided by the customer.A root cause was unable to be determined because the failure was unable to be replicated.H3 other text : see h.10.
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Event Description
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It was reported that the unspecified bd¿ infusion set tubing was expanded/bulged.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "two separate iv tubing reports.Rn noted the soft part of iv tubing has a bulge.".
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Search Alerts/Recalls
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