Catalog Number 395240 |
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 03/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that the septum of a bd connecta¿ stopcock was detached.There was no report of exposure, injury or medical intervention.
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Manufacturer Narrative
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Investigation summary: lot analysis: the lot number associated with this incident was unknown.Visual analysis: observations and testing: received a 3 way stopcock assembly with an extension set.The assembly consisted of a stopcock with an extension tubing bonded to one of its ports, a full q-syte assembly connected to another and a partial (top only) q-syte assembly bonded to the last of it ports.The partial assembly was missing the neck and the septum assembly.Visual/microscopic examination: observed the missing components of the q-syte (partial) unit had been separated at the weld joint.Observed traces of weld were present at the remainder component (partial q-syte).The weld was adequate and acceptable per specification.Observed there was damage (breakage) on the q-syte (full assembly) bottom body.Observed there was damage (breakage) on the stopcock valve (where the q-syte full assembly was connected).Investigation samples(s) meet manufacturing specifications: no.The upper components of a q-syte assembly were missing (detached).Damage (breakage) was observed on one of the stopcock ports and on the full q-syte assembly.Conclusions: confirmed the upper components of a q-syte assembly were missing (detached) and damage (breakage) was observed on one of the stopcock ports and on the full q-syte assembly.Root cause: relationship of device to the reported incident: indeterminate.Separation at the weld joint: traces of a weld line on the rim of the q-syte assembly; is an indication that a bond was provided during the manufacturing process.A definite cause that contributed to the separation could not be determined.Damage (breakage): damage appears to be caused by external forces applied to the unit during usage.
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Search Alerts/Recalls
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