Catalog Number 20128E |
Device Problems
Defective Component (2292); Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd alaris smartsite extension set was damaged the following information was received by the initial reporter with the following verbatim: i am looking for alternatives to our current filter we use in our nicu.We use ref 20128e bd smartsite extension set but are having issues with them blowing.Customer reply: ¿ what is the date of event? this has occurred several times over the past year ¿ please share the lot number.Don¿t have those numbers at this time ¿ describe any patient harm, injury, complication or negative outcome that occurred because of the event.Negative outcome is that we have to replace the filter.Potential harm is air embolism if we did not replace the filter.
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Event Description
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Additional information received.Material#: 20128e, batch number#: unknown.It was reported by customer that they are looking for alternatives to our current filter they use in our nicu.They use ref 20128e bd smartsite extension set but are having issues with them blowing.Verbatim#: rcc received a complaint via email.Email(s) attached.I am looking for alternatives to our current filter we use in our nicu.We use ref 20128e bd smartsite extension set but are having issues with them blowing.Customer reply: for the purposes of clarification, i want to define the word being used to describe your events "blowing" as not breaking, cracking, leaking or specifically occlusions but rather your infusions backing up the line.This is important for our data and to be on the same page.What is the date of event? this has occurred several times over the past year.Please share the lot number.Don¿t have those numbers at this time.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.Negative outcome is that we have to replace the filter.Potential harm is air embolism if we did not replace the filter.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? in the past we have thrown them away but i have asked staff to please keep any filters moving forward.Please share the captured photo of the event if available.Don¿t have any at this time.
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Manufacturer Narrative
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Date received by manufacturer updated.Short description correction.No product or photo was returned by the customer.The customer complaint of component damage - no leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 20128e because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been.
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Search Alerts/Recalls
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