Model Number 384466 |
Device Problem
Crack (1135)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2023 |
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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¿rn noted fluid/wetness when checking lines.Small amount of fluid noted at junction of peripherally inserted central catheter (picc) hub and extension set.Uncertain etiology so advised rn to perform sterile cap change/extension set change to determine if the cause was from the extension set or the actual picc.Upon disconnecting extension set, it was found that the actual hub on the picc line was cracked and causing the leaking.¿ update from (b)(6) 2023 @ 1306pm ¿ ¿picc insertion date (b)(6) 2023.Date of event (b)(6) 2023.Description of event-rn noted leaking at connection between blue lumen and extension set.A new picc and piv were inserted for completion of prescribed therapy.¿.
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Event Description
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¿rn noted fluid/wetness when checking lines.Small amount of fluid noted at junction of peripherally inserted central catheter (picc) hub and extension set.Uncertain etiology so advised rn to perform sterile cap change/extension set change to determine if the cause was from the extension set or the actual picc.Upon disconnecting extension set, it was found that the actual hub on the picc line was cracked and causing the leaking.¿.
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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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Search Alerts/Recalls
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