Model Number 384539 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Difficult to Flush (1251)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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Date picc placed (b)(6) 2022 @ 0930.Date of product experience (b)(6) 2022.Sku# 384539.Lot# 11410069.Describe event.Midline placed at 0930 with fluids infusing without issues until (b)(6) 2022 @1345 when prepping the neonate for lp rn noticed a yellowish color to the midline dressing and after further investigation found the dressing was wet.Ml dressing taken down to determine the cause of the leading.Ml would not flush so it was removed.After removal i flushed the line and the fluid was squirting out the side of the hub.The hub was cracked.And a new one placed any harm to patient? neonate did not receive medication that was infusing.Delay in care if so, please describe.Was a new piv placed for completion of prescribed therapy? was a new picc placed for completion of prescribed therapy? yes.Is product available for return? yes.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.Visual inspection confirmed a crack in the luer that would result in leakage.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 was initiated to address this issue.The capa is currently in the implementation phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.
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Event Description
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Date picc placed.(b)(6) 2022 at 0930.Date of product experience.8/12/2022.Sku# 384539.Lot# 11410069.Describe event.Midline placed at 0930 with fluids infusing without issues until 8/12/22 at 1345 when prepping the neonate for lp rn noticed a yellowish color to the midline dressing and after further investigation found the dressing was wet.Ml dressing taken down to determine the cause of the leading.Ml would not flush so it was removed.After removal i flushed the line and the fluid was squirting out the side of the hub.The hub was cracked.And a new one placed any harm to patient? neonate did not receive medication that was infusing.Delay in care ¿ if so, please describe.Was a new piv placed for completion of prescribed therapy? o was a new picc placed for completion of prescribed therapy? yes.Is product available for return? yes.
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Search Alerts/Recalls
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