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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reds1094 showed 68 other similar product complaint(s) from this lot number.
|
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), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of damaged packaging is confirmed; however, the exact cause is unknown.One photograph of two 20 g huber plus infusion sets with y-sites was returned for evaluation.An initial visual observation of the photograph showed the plastic trays of the infusion set packaging were warped, and the lid of the package appeared to be separated from the plastic tray on both samples.One of the valved y-sites also appeared to be warped and elliptical in shape; however, this was difficult to confirm from the returned photograph.While the warped packaging could be confirmed from the returned photograph, it was not possible to determine the root cause of this damage.However, possible causes include excessive or prolonged exposure to heat.A lot history review (lhr) of reds1094 showed 68 other similar product complaint(s) from this lot number.
|