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Model Number DFXL148MTE |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The entire catheter comes out of the patient, leaving the blue wing, that comes with the device from the factory, attached to the skin by the stitches.Catheter came out by itself.
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Manufacturer Narrative
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The device involved in the incident was not returned for evaluation and no photographs were provided.The device contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.A process review indicated that when attaching the suture wing to the hub, the operator must push firmly until the suture wing has entered the slot and is secured after the suture wing is assembled onto the hub, it is rotated several times to ensure free movement and proper positioning on the hub.A review of the engineering verification testing noted that all samples tested exceeded the suture wing iso pull force requirements.Without an evaluation of the device involved in the incident we are unable to determine the cause or factors that may have contributed to this event; however, it appears that enough force was applied to the catheter to dislodge it from the suture wing.
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Search Alerts/Recalls
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