Catalog Number UNKNOWN |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It has been reported that the unspecified bd¿ containment tube has been found experiencing erroneous results after use.The following has been provided by the initial reporter: material no.Unknown batch no.Unknown.It was reported that results that are not consistent with the patient¿s clinical condition.Per email: not proven to be a problem with the bd product, just clinician expectations.
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Manufacturer Narrative
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Investigation summary: the customer did not provide bd pas with product catalog number or lot number information, when requested.After 3-follow-up attempts to obtain additional information, bd pas has closed this customer complaint.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.
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Event Description
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It has been reported that the unspecified bd¿ containment tube has been found experiencing erroneous results after use.The following has been provided by the initial reporter: material no.Unknown.Batch no.Unknown.It was reported that results that are not consistent with the patient¿s clinical condition.Per email: not proven to be a problem with the bd product, just clinician expectations.
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Search Alerts/Recalls
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