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Model Number SRD6108 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This is one of twelve products involved with the reported event.The medical device reporting reference number for these events are 9616099-2019-03078, 9616099-2019-03135, 9616099-2019-03136, 9616099-2019-03137, 9616099-2019-03138, 9616099-2019-03139, 9616099-2019-03140, 9616099-2019-03141, 9616099-2019-03142, 9616099-2019-03143 and 9616099-2019-03144.This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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The luer lock fitting on the 4f tempo aqua.038" 125cm vert diagnostic catheter was not engaging properly with the syringe and was thus leaking.The procedure was successfully completed and there was no patient injury.The device will be returned for analysis.The procedure being performed was peripheral interventions on the legs.The leakage was noted when flushing the device.The user continued to use it and tried to stop/minimize the leaking.No additional patient or procedural details are available.
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Manufacturer Narrative
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The luer lock fitting on the 4f tempo aqua.038" 125cm vert diagnostic catheter was not engaging properly with the syringe and was thus leaking.The procedure was successfully completed and there was no patient injury.The procedure being performed was peripheral interventions on the legs.The leakage was noted when flushing the device.The user continued to use it and tried to stop/minimize the leaking.No additional patient or procedural details are available.The device was not returned for analysis as it was discarded after the case.A product history record (phr) review of lot 17833134 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿luer hub ¿ catheters - incompatibility/fit - with syringe¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors may have contributed to the reported event.Per the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.For all catheters: keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ neither the phr review nor the information available suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.
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Search Alerts/Recalls
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