Model Number M001271800 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Same case as mdr id: 2134265-2018-07014.It was reported that foreign matter was observed on the device.Two 10.3 flexima¿ drainage catheters were selected for use.During the procedure, the physician put two flexima¿ catheters in the patient; however, it was noted that both catheters leaked around the hub.It was further noted that there was like a small piece of a thread coming out of the catheter hub where the physician thought it was leaking.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the catheter returned was cut at 10cm from the proximal end.No foreign matter were noted in the returned hub.Only the suture string was observed at stopcock of the hub and the hub looks under good conditions without evidence of damages or anomalies.Water was injected using a syringe through the hub and no leaks were found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
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Event Description
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Same case as mdr id: 2134265-2018-07014.It was reported that foreign matter was observed on the device.Two 10.3 flexima drainage catheters were selected for use.During the procedure, the physician put two flexima catheters in the patient; however, it was noted that both catheters leaked around the hub.It was further noted that there was like a small piece of a thread coming out of the catheter hub where the physician thought it was leaking.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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