H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse 035 pta dilatation catheter returned loaded and stuck with an unknown introducer sheath for the evaluation.On the visual evaluation, the device was noted bloody.The distal tip of the sheath was noted to be buckled and the bunching also noted throughout the introducer sheath.No other anomalies were noted to the sample.No other functional testing was performed due to the condition of the returned device.Therefore the investigation for the reported difficult to remove was confirmed, as the balloon returned loaded and stuck with an unknown introducer sheath for the evaluation.A definitive root cause for the reported difficult to remove could not be determined based upon the provided 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: 09/2023).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.H3 other text : see h10.
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