Catalog Number UNKNOWN |
Device Problem
Backflow (1064)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2023 |
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 franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using an unspecified bd extension set there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: the secondary medication was back-flowing into the primary infusion bag rather than free- flowing into the patient.
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Manufacturer Narrative
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H6: investigation summary due to no material, batch, or sample being received, investigation could not be performed and the production records could not be evaluated.It was reported by customer that "the secondary medication was back-flowing into the primary infusion bag " could not be verified and the root cause remains unknown.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
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Event Description
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It was reported while using an unspecified bd extension set there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: the secondary medication was back-flowing into the primary infusion bag rather than free- flowing into the patient.
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Search Alerts/Recalls
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