TELEFLEX MEDICAL SDN. BHD. HUMID-VENT FILTER COMPACT STRAIGHT; FILTER, BACTERIAL, BREATHING-C
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Model Number IPN043768 |
Device Problem
Disconnection (1171)
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Patient Problem
Capsular Contracture (1761)
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Event Date 04/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that prior to use while assembling the tubing, the filter does not stay attached to the tubing and disconnects from the whisper swivel valve easily, even if the tubing is not moved.Additional information received states that the filters are compatible with the swivel valve.No patient involvement.
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Manufacturer Narrative
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Qn#: (b)(4).Other remarks: n/a.Corrected data: n/a.
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Manufacturer Narrative
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(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "based on the returned sample provided, gauge tests was conducted on the connectors of the complaint sample.All the connectors side is in the specification according to iso 5356-1:2015.In current manufacturing procedure, iqc department will conduct sampling gauge test before release the part item to production.In production, 100% visual inspection at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment." a device history record review was performed and no relevant findings were identified.The complaint cannot be confirmed as the returned device was found to be within specification.Other remarks: n/a corrected data: n/a.
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Event Description
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It was reported that prior to use while assembling the tubing, the filter does not stay attached to the tubing and disconnects from the whisper swivel valve easily, even if the tubing is not moved.Additional information received states that the filters are compatible with the swivel valve.No patient involvement.
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Search Alerts/Recalls
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