Model Number EL-NC1001 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Pain (1994)
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Event Date 06/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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Although requested the product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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The customer reported that the neutraclear piston/gland was stuck and remained in the down position which caused the chemotherapy to be unable to infuse.The nurse held the infusion, flushed the port with normal saline and reconnected the tubing set to find that the piston/gland was stuck in the down position.The neutraclear valve was changed and the piston/gland for the second neutraclear valve was also stuck and remained in the down position.The neutraclear was replaced again with a third neutraclear valve with no further reports of complications.The patient complained of pain at the port site and experienced multiple unnecessary line entries.There was no lasting harm caused to the patient.
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Manufacturer Narrative
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The customer¿s report that the neutraclear piston/gland remained stuck down (recessed) was confirmed.Visual inspection of the set noted that the orange piston was recessed at an angle with the inner needle appearing to be damaged.Functional testing confirmed the valve was stuck in the depressed position.After disassembly, it was observed that the needle of the valve was damaged/crushed.The mating component (syringe) was not returned for investigation.The set was within specification.The root cause was not identified.
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Event Description
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It was reported that when the patient complained of pain at the port site during a vincristine chemotherapy infusion, the nurse flushed the port with normal saline and reconnected the chemotherapy infusion tubing set; however the chemotherapy agent would not infuse because the orange piston of the neutraclear valve remained depressed after the syringe was removed.The neutraclear valve was reported to have been in use for less than 2 hours.The nurse disconnected the chemotherapy tubing set and changed the neutraclear valve; the second neutraclear valve remained depressed as well.The valve was changed again without any further complications.The nurse further stated that she spent one hour in the patient room to administer a 5 minute and 15 minute chemotherapy infusion, including multiple and unneccessary line entries.There was no lasting harm caused to the patient.
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Search Alerts/Recalls
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