Model Number 384539 |
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 05/19/2023 |
Event Type
malfunction
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Event Description
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The argon picc was successfully inserted (b)(6) 2023 at 1400h, in an infant on day 3 of life.Site was the left antecubital.Tpn, smof, fentanyl and heparin infusions were started.Day 5 of life, (b)(6) 2023 picc was noted to be leaking at 1700h.Central line was removed.The hub was noted to be cracked.On (b)(6) 2023 at 0400h, the same picc was inserted into a scalp vessel (right side) on this same infant, who required central venous access.The picc was noted to be leaking by 1700h.It was removed.One of these 2 piccs (identical lot number) was saved in a biohazard bag for the company to inspect the defect.
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Manufacturer Narrative
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Sample is not available for return.The event is getting investigated.A follow-up report will be submitted upon investigation conclusion.
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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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The argon picc was successfully inserted (b)(6) 2023 at 1400h, in an infant on day 3 of life.Site was the left antecubital.Tpn, smof, fentanyl and heparin infusions were started.Day 5 of life, (b)(6) 2023 picc was noted to be leaking at 1700h.Central line was removed.The hub was noted to be cracked.On (b)(6) 2023 at 0400h, the same picc was inserted into a scalp vessel (right side) on this same infant, who required central venous access.The picc was noted to be leaking by 1700h.It was removed.One of these (b)(4) piccs (identical lot number) was saved in a biohazard bag for the company to inspect the defect.
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Search Alerts/Recalls
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