SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY IV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Model Number 307300 |
Device Problems
Material Frayed (1262); Material Perforation (2205); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that the catheter tips were fraying upon insertion.The needle was poking through catheter tip.The needle tip was bent prior to packages being opened and the catheter was flimsy enough to be bent with air blowing on it, causing multiple sticks upon insertion.No patient injury was reported.
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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: 3012307300-2022-06649.The report was submitted in error.
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Search Alerts/Recalls
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