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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20075058.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 21015542.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 21015540.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 20085530.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 20075926.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one mz1000 sample was received without packaging for investigation.The customer feedback indicates that the affected product was from either lot 21015542, 21015540, 20085530, 20075926 or 20075058.A visual inspection of the returned maxzero identified a crack on the female luer adaptor (fla) of the component (appendix 1).During functional testing leakage was observed from the crack.The details of this feedback were forwarded to the manufacturing site for investigation.They performed an in-depth investigation in order to determine a potential root cause for cracks of this nature; during the investigation no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed damage.A review of the production records for lot 21015542, 21015540, 20085530, 20075926 and 20075058 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although a definitive root cause could not be determined in this instance, previous investigations have confirmed similar damage can be caused or contributed to by a combination of different factors, including prolonged use of substances that are aggressive to plastics, over-torque of the component during connection with the male luer, or use of a male luer that is not compliant to iso standards.In this instance the customer confirmed that the damage was observed after the maxzero had been in use for one and a half months; please note that the dfu for the maxzero states "change according to facility protocol or in accordance with currently recognized guidelines for iv therapy, such as every 7 days or 200 activations".A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mz1000 product in the past 12 months.
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