SMITHS MEDICAL ASD, INC. JELCO CONVENTIONAL PLUS IV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC,
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Catalog Number 7065-AI |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that the customer found it difficult to channel the venous access on a patient.No patient injury was reported.
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Manufacturer Narrative
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This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No problems or issues were identified during this device history record review.D4: udi information is unknown.G5: premarket (510k) number is unknown.
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Search Alerts/Recalls
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