The clinician had used two of the demo samples on two patients and indicated that the other 8 x demo needles were not used.7 x unused devices from lot: a1140913 were returned for evaluation.During visual inspection it was confirmed that the devices all had the additional labelling (yellow demo label) affixed, and the sterile barrier of the packaging had a cut, indicating that these are demo devices and, consequently, should not be used on patients.Review of device history record (dhr) found that work orders for lot: a1140913 appear complete and correct.There were no temporary deviations or non-conformance's at the time of manufacturing.The associated inspection record confirms that the product was manufactured to specification.It has been established that the sales representative inadvertently ordered ¿demo samples¿ which are un-sterilised samples.This order was processed in the distribution centre where the non-sterile labelling was applied, and the samples were made un-sterile by cutting the sterile barrier packaging.The order was shipped directly to the sales representative; they did not open the box and as a result did not see the non-sterile labelling on the packages before shipping the package on to the customer.The customer appears to have opened the packaging of the devices without noting the non-sterile labelling on the packaging and then used 2 of the devices on patients.The laboratory team leader at the manufacturing facility was consulted on the reported event, and he stated the following: "i can say from the last few years of historical testing data in relation to our ivf needle range is that: 1.Our bioburden pre-sterilisation testing has remained consistently below 200 cfu/device.2.Our endotoxin testing has remained below 1 eu/device.¿ the complaint information was provided to the medical advisor in order to provide a clinical assessment, which stated the following: ¿accepting that the needles were initially sterilized after a routine manufacturing process restricts the possible organisms involved a lot.Haematogenous spread is not possible, and the risk of significant infections is reduced, but not zero, mainly due to the organisms that populate surfaces, not all of which are pathogenic.¿ additional information was received from a cook medical quality assurance senior manager."as per our global policy there are different types of orders for samples, the type of sample is to be communicated by the sales representative to customer support.In this case, a demo sample was requested.The order was correctly placed by the customer support (cs) team as a demo sample.The order went to the distribution centre to be fulfilled as a demo order, this means the products are selected from stock and they then go to get the additional labelling (yellow demo label) and to be de-sterilised which is breaking the sterile barrier with a cut.This was completed as per process.¿ the sales representative received the samples and sent them straight to the customer, the customer used the product and only saw the label after the use of two needles.Please note that a service complaint has been raised against the divisional sales group to assess for actions that can be taken with regards this issue.¿ the sales representative was retrained on the policy for ¿health care professional interactions - evaluation and demonstration products (samples) (evdm).Additionally, communication was sent out to all division and sales team members as a reminder of the distinctions between ordering a demo and/or sample.' a review of the manufacturing records and/or specifications did not reveal any discrepancies that could have contributed to this complaint issue.The investigation concludes the complaint device was manufactured to specification.A definitive root cause was identified.The reported event was caused due to the way the samples were ordered.As the term 'demo' was used, the needles were dispatched in an un-sterilized condition, and their packaging was intentionally cut.Unfortunately, the clinician was unaware of this distinction and overlooked the yellow label indicating their non-sterile status.A definitive root cause was identified.The reported event was caused due to the way the samples were ordered.As the term 'demo' was used, the needles were dispatched in an un-sterilized condition, and their packaging was intentionally cut.Unfortunately, the clinician was unaware of this distinction and overlooked the yellow label indicating their non-sterile status.
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