Catalog Number ES-04301 |
Device Problems
Migration or Expulsion of Device (1395); Off-Label Use (1494)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported "on (b)(6) 2023, the patient's abdominal drainage tube was inserted with a 14cm internal tube and fixed with a patch.The puncture point exuded fluid on (b)(6) 2023 and at 19:00, the duty doctor made a pocket at the insertion site for use.At 20:30, the nurse found that the tube had a built-in 11cm mark during the ward inspection, and informed the duty doctor.Upon examination by the bedside, it was indicated that no treatment was needed.On the morning of march 17th, it was found that all the catheters had slipped out and were coiled in the stoma bag.The drainage tube was not fixed with sutures." the patient's condition was reported as fine.
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Event Description
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It was reported "on (b)(6) 2023, the patient's abdominal drainage tube was inserted with a 14cm internal tube and fixed with a patch.The puncture point exuded fluid on (b)(6) and at 19:00, the duty doctor made a pocket at the insertion site for use.At 20:30, the nurse found that the tube had a built-in 11cm mark during the ward inspection, and informed the duty doctor.Upon examination by the bedside, it was indicated that no treatment was needed.On the morning of (b)(6), it was found that all the catheters had slipped out and were coiled in the stoma bag.The drainage tube was not fixed with sutures." the patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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