(b)(4).Twelve samples were received for evaluation; during visual inspection it was observed that between the resuscitator and housing 6 of the samples contained uv glue which was not cured, 4 eaches had uv glue which was not applied properly, and 2 eaches were detached.Additionally, the housing 30mm exhalation port with p/n: 65-4213e was submitted to ir scan in order to determine if the samples received for evaluation correspond to resin k or if another characteristic was present which could cause the housing to detach from the resuscitator.In result, no differences were detected between the three reference materials submitted.The device history record for the lot reported was evaluated for any issues related to the reported issue.The product was manufactured, inspected and released in accordance with all internal procedures and no issues were observed.Two years of complaints were reviewed from july 1, 2014 - june 30, 2016 and no trend was detected.It is possible that personnel could be related to this failure, however, due to inconclusive results of the investigation (b)(4) has been created to further define the final root cause and potential corrective actions.The complaint will be closed at this time and (b)(4) may be referenced.
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