SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY I.V. CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Model Number 307300 |
Device Problems
Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the white catheter piece has either been bent or torn before use or has failed upon use.There was no patient injury reported.
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Manufacturer Narrative
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The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
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Manufacturer Narrative
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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: the report was submitted in error., corrected data: corrected information provided in h10.
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Search Alerts/Recalls
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