One single dpt - vamp jr.Kit from the reported model and lot number in an open tyvek pouch was returned for examination.The reported event of "tubing for the arterial line was broken" was confirmed.The pressure tubing was broken from the bond joint that connects to the vamp jr.Reservoir.The cross surfaces of the broken tubing appeared uneven and rough.No other damage was observed from the kit.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.In addition, they are used in critical care units or ors where patients are closely monitored.If the pressure tubing breaks 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 involvement.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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