SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Model Number 308300 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2022 |
Event Type
malfunction
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Event Description
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It was reported that following insertion of an iv catheter, iv was noted to be leaking from where the hub of the iv connects to the cannula.The iv had to be removed.No apparent harm to the patient.No other information has been provided at this time.
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Manufacturer Narrative
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Other text: a device history record (dhr) investigation suggests that the defective sample consists in an isolated occurrence caused by a temporary misalignment of the assembly station.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection confirmed the catheter tube was damaged in proximity of the hub, thus causing the leakage.Functional testing found leakage.The root cause of the reported issue was found to be manufacturing.No corrective action will be implemented at this moment; however, we will monitor the recurrence of this type of defect and if a trend will be identified, a corrective action will be recommended.
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Manufacturer Narrative
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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: 3012307300-2022-10101.The report was submitted in error.
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Search Alerts/Recalls
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