D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text: see h.10.
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It was reported while using bd luer-lok¿ 1-ml syringe the plunger rod bent.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: the quality seems to have deteriorated in the past, so that the plunger bends or even breaks! it is not possible to define exactly when the case occurred for the first time, but it has become more noticeable in the last 2-3 months.X-ray contrast medium solutrast 300 and embolisation particles for angiographic interventions were administered.Both were injected via microcatheter and during this procedure the plunger bent or broke off.Patients were not harmed, but material consumption was higher and examination time increased because new syringes had to be fetched.Almost every syringe that was used with increased pressure was affected.
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