One single dpt - vamp jr.Kit was returned for examination.The reported event of damage to the device was confirmed.The pressure tubing was found broken from the bond joint connected to the lower tube of the proximal sample site.The cross surfaces of the broken tubing appeared uneven.In addition, the tubing had detached from the bond joint with a vamp reservoir stopcock.Indications of bonding solvent were evident on some locations of tubing bond surface area.The tubing outer diameter was measured near the point of detachment and was found to be within specification.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.It is common clinical practice to inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.In this event, there was no patient compromise noted as the issue was found before use.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.(b)(4).
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