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 12/12/2022 |
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.(b)(4).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 came apart during use on a patient.The following information was provided by the initial reporter: "abruptly come apart while connected to a patient".
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Event Description
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It was reported that the unspecified bd¿ infusion set came apart during use on a patient.The following information was provided by the initial reporter: "abruptly come apart while connected to a patient".
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Manufacturer Narrative
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One photo was received from the customer with the complaint of separation.The photo clearly shows the separation described and the complaint has been verified.Without further information like the physical sample for testing, the root cause of this failure remains unknown.The manufacturer of this set has been notified of this failure.A device history record review for model mx5301 lot number 22099253 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h10.
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Search Alerts/Recalls
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