Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001315906.Medical device expiration date: unknown.Device manufacture date: 2019-08-14.Medical device lot #: 0001318731.Medical device expiration date: 2021-05-31.Device manufacture date: 2019-09-05.Initial reporter facility: the user facility address is not available, the corporate headquarters information was used instead.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
H.6.Investigation summary no samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed.However, the investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted.Specific to the handling of the drugs, the investigation noted specific procedures to control the handling of any raw material drug component during the receipt, storage, and use in the manufacturing process.A review of the temperature monitoring system within the mannford facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any corrective actions for this complaint.Based on the reported failure mode, supplier quality notifications was sent to the vendor to notify the vendor of the reported failure mode.Likewise, the complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis process if an adverse trend is identified.A device history record review of all applicable manufacturing records for lots 0001315906 and 0001318731 did not identify any issues that may have contributed to the reported failure mode.
|