Catalog Number UNKNOWN |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2022 |
Event Type
malfunction
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Event Description
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It was reported when using an unknown bd arterial blood collection syringe the blood sample cannot draw back by itself.The following information was provided by the initial reporter.The customer stated: "when using an arterial blood sampler to collect blood from a patient, the blood sampler cannot draw blood back by itself.".
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.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.Device manufacture date: unknown.
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Manufacturer Narrative
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Investigation summary: material # unknown; lot/batch # unknown.Bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported when using an unknown bd arterial blood collection syringe the blood sample cannot draw back by itself.The following information was provided by the initial reporter.The customer stated: "when using an arterial blood sampler to collect blood from a patient, the blood sampler cannot draw blood back by itself.".
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Search Alerts/Recalls
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