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Model Number 306301 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that there were nine attempts to place an iv.The initial attempt and second attempt did not result in blood return.The cat scan department had no issues getting a vein but the iv safety catheters would not disconnect and the entire iv would come out in one piece.This occurred four times.Additional attempts were made on a bed sheet to see if the iv catheter could disconnect and it would not.After eight attempts of starting an iv site the patient was started.After the patient's scan was started the iv site stopped working 37 minutes into the test.The site was inserted with an ultrasound and a new box of catheters.
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Manufacturer Narrative
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Other, other text: three units were returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.Packaging lot 4068767 was produced on pcm3 on 15, 16oct20 ((b)(4)).Nonconformance data identified one in-process nonconformance, however, the nonconforming product was from totes not included in lot 4068767 and was scrapped 100 percent.Based on analysis of unused samples, the complaint cannot be confirmed as a manufacturing nonconformance.
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Manufacturer Narrative
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Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-06530.The report was submitted in error.
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Search Alerts/Recalls
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