H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one unsealed pristine 23cm catheter kit was returned for evaluation and two electronic photos were provided for review.Gross visual and dimensional evaluations were performed on the returned device.The dimensions measured during sample evaluation does not match the dimensions of the device (rm1923102) with the reported lot which is a 23cm catheter.Moreover the dimensions of the returned device matches with the material (rm1923104) which is a 33cm pristine catheter.However upon further review on the manufacturing, packaging, biomerics, printing and stocking process of the device with the particular lot shows no discrepancies noted related to incorrect sized device within package or incorrect specification printed on device.Therefore, the investigation is inconclusive for the reported inaccurate information, component misassembled and component missing issues as the device was returned with the packaging in unsealed condition and moreover the exact circumstances upon opening the package are unknown.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2023).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.
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