Model Number 66-2504 |
Device Problems
Fitting Problem (2183); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Protocol number is blank as device is exempt.Investigation, including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the seal that holds the one end piece into place can be pulled off.The given part number was (b)(4).There has been no report of observable clinical symptoms or a change in symptoms identified in the patient as this was found in pre-test.
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Manufacturer Narrative
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Device evaluated by manufacturer and health impact, event problem and evaluation codes: updated.Device evaluation: one (1) device was received.Upon visual inspection the device looked properly assembled.Unit not missing heat stakes fitting look properly attached.Proceeded with pull test and failed.Connector separated from assembly confirming the complaint.Failure may have occurred during manufacturing assembly at one (1) heat stake affixing 15mm connector to 15mm flex tube because heat stake did not fully penetrate tubing into fitting.A device history record (dhr) review showed no reported discrepancies during the manufacturing of the reported lot number.No action taken.
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Search Alerts/Recalls
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