Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: the corrective action statement is approved / authorized and final review of the complaint will be conducted by the designated complaint handling unit (dchu).Investigation completed by: (b)(6).(b)(4) ¿ mdr no sample.Part #: 384021 ¿ 26 g (1.9 fr) x 1.9 cm bd introsyte-n precision introducer for picc and midline catheters with bd instaflash needle technology.Lot #: 5055718 (sub-assembly p/n y2566aal, l/n¿s; 5055704, 5026572 and 5026569).Complaint: other.Customer verbatim: introducer stuck in vein.Lot analysis: device/batch history record review: yes.Reason: dhr¿s are available for review as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr).Findings: mdr: review was conducted.(b)(4).Review of dhrs revealed all required samples and testing was conducted per specifications and in accordance with the in-process sampling plans.Review disclosed no related reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.Mrr / sap-qn database review: yes.Reason: this database tracks any issue during production that would affect product quality.Findings: subject code was an s2 severity ranking.Review was conducted for this mdr-level a investigation; as a result of the review, there were no reject activity findings relevant to the defect stated in the pir related to the lot number and the sub-assembly lot numbers associated with this incident.Observations and testing: observations and testing could not be performed because units were not received for investigation of this incident.Investigation samples(s) meet manufacturing specifications: unknown; units were not received for observation and testing.Investigation conclusion: confirmation of the defect stated in the subject of the pr could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing.Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defects stated in the pr.This incident is indeterminate.Root cause description: indeterminate.Comment: units not provided for investigation of the incident stated in the pr.
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