ARROW INTERNATIONAL LLC CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI
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Catalog Number CAR-02400 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2024 |
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 that"10 jan 2024, the luer hub was found a crack during used on the patient.
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Manufacturer Narrative
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(b)(4).The report of a cracked luer hub was confirmed through complaint investigation of the returned sample.The customer returned one hem o dialysis connector assembly for evaluation.Signs-of-use were observed on the returned device.Visual inspection of the connector revealed the venous (blue) luer hub was cracked at the threads.This damage is consistent with repeated overtightening of the hubs during use.A lab inventory syringe filled with water was attached to the blue extension line and flushed.Water was observed leaking out of the crack on the blue venous luer hub's threads.The ifu provided with the kit informs the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that "on (b)(6) 2024, the luer hub was found a crack during used on the patient.
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Search Alerts/Recalls
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