Catalog Number 300865 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown. device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that cair tubing became separated from a bd plastipak¿ 50 ml concentric luer lock syringe during use.In addition, it was reported that the tubing was either difficult to connect to the syringe or disconnected easily.There was no report of exposure, injury or medical intervention.
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Manufacturer Narrative
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No samples or pictures have been received for investigation.Since lot number is unknown, no retained samples can be evaluated.Device history record cannot be evaluated since lot number is not available.Thread and tip verification is done with an iso-594 compliant gauge pass/non pass in the first lot per manufacturing line.It is also checked leakage in conical fitting test according to procedures.Final products in this manufacturing line, for this reference and lot size 22pallets are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Capa initiation determination: no corrective action is taken.With the info available no further investigation can be done.
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Search Alerts/Recalls
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