H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a foreign material within a kit is confirmed and was determined to be manufacturing related.One 4 fr single lumen powermidline catheter kit was returned for evaluation.An initial visual observation showed the kit was returned open, but the contents appeared unused.Multiple small pieces of a brown material were observed on the outside of the csr wrap within the kit.A larger piece of this material was observed in the adhesive strip underneath the outer ¿side car¿ of the kit.A microscopic observation revealed the material pieces were mostly flat and fibrous.Small bits of blue and green were observed in some of the material pieces.The material was also observed to break apart somewhat easily when handled.The investigation was forwarded to the manufacturing facility for further evaluation.Reynosa evaluation: complaint due to ¿cardboard shavings in the sealed kit¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross, microscopic visual evaluation performed at vad lab the following was concluded: several residues of cardboard shavings were found to be deposed over the blue crs wrap.The foreign material is brown color similar to the color material of boxes used for packaging.This condition makes the kit unsafe for our customer.Therefore, the cause of this condition is manufacturing related.As part of reinforcement about this issue, an awareness communication was provided to all personnel involved on this operation.A lot history review (lhr) of redu2772 showed no other similar product complaint(s) from this lot number.
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