It was reported the needle hub separated from the needle.During ultrasound-guided picture, wire is placed without problems but when removing the cannula, the cannula remains in the tissue - breaks at base but can be removed without problems.No patient harm reported.The patient's current condition is reported as "released".It was reported the needle came in contact with octenisept disinfectant.
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(b)(4).The customer returned an introducer needle for analysis.Signs of use in the form of biological material was observed.Visual analysis revealed that the needle hub was broken and separated.A portion of the distal end of the hub was still adhered to the needle cannula.Microscopic examination revealed that the point of separation was slightly rough and not uniform.Additionally, a small portion of the hub also became separated from the assembly.When reassembled, a notch was observed in the needle hub which is consistent with the new hub design.Functional inspection could not be performed due to the damage to the needle hub.The hub of the needle was tested with the male luer gage and was within the specified range.This indicates that the luer conforms to iso 594-1:1986.A device history record review was performed, and no relevant findings were identified.The report of a separated needle hub was confirmed by complaint investigation of the returned sample.Visual examination revealed the hub was separated.The hub of the needle was tested with the male luer gage and was within the specified range, indicating that the luer conforms to iso 594-1:1986.A device history record review was performed, and no relevant findings were identified.Based on the sample provided , design caused or contributed to this event.Further investigation of this issue is being performed under a capa.Teleflex will continue to monitor and trend for reports of this nature.
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It was reported the needle hub separated from the needle.During ultrasound-guided pucture, wire is placed without problems but when removing the cannula, the cannula remains in the tissue - breaks at base but can be removed without problems.No patient harm reported.The patient's current condition is reported as "released".It was reported the needle came in contact with octenisept disinfectant.
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