H.6.Investigation summary (b)(4).¿ scope of issue: solution part#: 340345 , bd facsclean 5l, lot #2201409824 ¿ problem statement: customer reported that they received a solution with lot and expiration date swapped around in the product label.¿ manufacturing defect trend: this product is manufactured by a third party.Manufacturing non-conformance data are not routinely available.¿ batch history record (bhr) review: batch production record for product 3928 was reviewed by the supplier.The materials met all the manufacturing specifications prior to release, and no deviations were reported.¿ complaint trend: there are 3 similar complaints, other than this complaint that were found.Date range from 15sep21 to 15sep22.¿ retain sample evaluation/testing: supplier has reviewed their retain sample, and identified impacted lots with labels.¿ returned sample evaluation: there is no sample returned, photo of label were provided and attached in the complaint.¿ investigation and root cause analysis: per supplier¿s note, as part of the investigation, they reviewed their process of printing labels and label management.They noted in 2021, there were changes made to the template of labels applied to bd products.In addition, their printing system has also changed.However, the interface between their erp system and the printing system was validated, hence there is no errors in the data transmission between the systems.Hence, the likely root cause of this complaint was the use of incorrect templates for printing labels.Impacted lots number were identified and communicated with bd quality.The supplier is in progress of implementing corrective action for this issue.(b)(4).¿ risk analysis ¿ this solution is a general purpose ivd class i product, which is an ancillary to the flow cytometer.It is not a component of the reagent or stained sample solution; it is not used in conjunction with cytometric data acquisition.Based on cpo-045, severity: s1, occurrence: o2 risk: low ¿ conclusion: based on the investigation result, the complaint is confirmed.¿ root cause: based on the investigation result, the complaint root cause is confirmed by the supplier.The supplier has implemented the corrective action for this issue.
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