Catalog Number 2420-0007 |
Device Problem
Defective Component (2292)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/29/2024 |
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 pump module smartsite infusion set was damaged the following information was received by the initial reporter with the following verbatim hole was found in iv tubing.Catalog#: 2420-0007.
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Event Description
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No additional information was provided.
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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint of hole in tubing 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 2420-0007 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.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 helpful in trend identification and supporting our commitment to continuous quality improvement.
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Search Alerts/Recalls
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