Catalog Number UNKNOWN |
Device Problem
Backflow (1064)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/11/2023 |
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 in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that unspecified bd infusion set had flow issues.The following information was received by the initial reporter with the verbatim: i have had a recent issue in the chemo suite with a chemo drug not infusing properly to the peripheral line.We are not sure if we are experiencing faulty tubing or faulty phaseal products.Despite being programmed on a pump correctly when started the secondary line was running at a fast rate and it appeared to be infusing up to the primary line (despite clamps being in place) not to the patient.There is now chemo in the primary and secondary line.
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Manufacturer Narrative
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Investigation summary no product or photo was returned by the customer.The customer complaint that there was back flow could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Event Description
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It was reported that unspecified bd infusion set had flow issues.The following information was received by the initial reporter with the verbatim: i have had a recent issue in the chemo suite with a chemo drug not infusing properly to the peripheral line.We are not sure if we are experiencing faulty tubing or faulty phaseal products.Despite being programmed on a pump correctly when started the secondary line was running at a fast rate and it appeared to be infusing up to the primary line (despite clamps being in place) not to the patient.There is now chemo in the primary and secondary line.
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Search Alerts/Recalls
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