Catalog Number 42502E |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.You would add the known lot number in the complaint and then add there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: unknown, medical device expiration date: unknown, and device manufacture date: unknown.
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Event Description
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It was reported that 2 bd alaris¿ smartsite¿ gravity set came without clamps.The following information was provided by the initial reporter: i am aware of at least four without clamps.
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Manufacturer Narrative
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Investigation summary: no product or photo was returned by the customer.The customer complaint of misassembly and tubing defective / damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model 42502e lot number 22069211 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 2 bd alaris¿ smartsite¿ gravity set came without clamps.The following information was provided by the initial reporter: i am aware of at least four without clamps.
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Search Alerts/Recalls
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