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Catalog Number H96560M0721311 |
Device Problem
Uncoiled (1659)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The used guidewire was returned to angiodynamics.As this is a purchased component, it has been forwarded to the supplier, heraeus medical, with a supplier corrective action request (scar).Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
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Event Description
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After placing a midline catheter in the patient's left arm, the complaint reporter "went to remove the guidewire with the inner part of the dilator and they were both coming out and at the very end.The guidewire was floppy." it appeared to have uncoiled.The used device has been returned to angiodynamics for evaluation.
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Manufacturer Narrative
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A review of the device history records (dhr) was performed for the indicated packaging and picc assembly component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "guidewire unraveled." no adverse trend was identified.As the guidewire is a purchased component for angiodynamics, the returned sample was forwarded, along with a scar (supplier corrective action request) to lake region medical components, the manufacturer.Their visual observation found that : the guidewire was unraveled beginning at the proximal weld and extending approximately 33cm distal of the proximal joint.A kink was also present in the core wire.The returned guidewire was incomplete in that the distal weld was not present on the returned guidewire and the ball weld was not present on the returned core.Lake region's conclusion was that based on the evidence presented by the sample and the information provided by the supporting documentation, improper use, improper handling, excessive force, and/or improper removal from packaging appear to have impacted on the event as reported.Lake region medical also performed a dhr review of the reported lot and found no indication of a manufacturing defect that could have impacted the reported event.(b)(4).
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Search Alerts/Recalls
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