(b)(4).A device history record review was performed on the epidural needle with no relevant findings.The customer reported the epidural needle bent during use.The customer returned one epidural needle (reference attached files (b)(4)).The returned needle was visually examined with and without magnification.Visual examination of the returned needle revealed the needle appears used.The cannula of the returned needle is bent.Microscopic examination of the needle bevel revealed biological material can be seen on the needle's bevel.Also, the needle's bevel tip is slightly bent.The needle bevel appearance is similar to a needle bevel that has been pressed against a hard surface with force (reference files (b)(4)).A dimensional inspection was performed on the returned epidural needle.The outer dimension (od) and inner dimension (id) of the returned needle was measured.The od of the returned needle measured 1.46mm (c05155), which is within specification of 1.46mm-1.48mm per graphic (b)(4); rev 7.The id measured 0.046in (1.17mm) (c05157), which is within specification of 1.17mm per graphic (b)(4); rev 9.Other remarks: additional testing of the needle tips was performed by the manufacturing site to determine tip strength.Testing was performed to compare needle tips strengths from five available sets of different needles.The test concluded that the needle sets had very similar results.Specifications per graphic (b)(4); rev 7 and (b)(4) rev.9 were reviewed as a part of this complaint investigation.A review of design change history for part number (b)(4) was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.A review of the quality inspection report from the vendor of the cannula (b)(4) found no material issues for lot # 72p15j0017 (vendor lot # mm150805aj).The reported complaint of the needle being bent during use was confirmed based on the sample received.Visual examination of the returned needle revealed the cannula was bent.Also, the tip of the needle bevel was slightly bent, which is consistent with damage that can be caused when a needle bevel is pressed against a hard surface.A device history record review was performed on the epidural needle with no relevant findings.No material issues were found from the vendor for the cannula.Also, a needle tip strength study was performed by the manufacturing site which revealed very similar results with five different sets of needles indicating that the needle in question does not show any material deficiencies or changes.Therefore, based upon the information provided, the observed needle damage, and the time of discovery, operational context caused or contributed to this event.However, based on the increased number of bent needle complaints, capa request was initiated to further investigate this complaint issue.(b)(4).
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