Model Number MX2341L |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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No product returned and no photos were provided by the customer for investigation of the reported complaint.The complaint cannot be confirmed.Device history record and inspection paperwork were reviewed and found no indication of issues with the parts tested during the production run.Maintenance work order history was also reviewed and found no reported maintenance work done during the time frame that the lot was produced.On hand quantity has been reviewed and found no stock remaining on hand.Complaint data was also reviewed and found one other complaint in the last two years that could not be verified due to no product being returned and no photos being provided.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.Pma/510(k) number: unknown.
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Event Description
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It was reported that the 4- way stopcock kept disconnecting from the iv line although the nurse screwed it in securely.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-26332.The report was submitted in error.Corrected data: corrected information provided in h10.
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Search Alerts/Recalls
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