As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.Expiry date: 01/2026.
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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 9fr hickman d/l catheter was returned for evaluation and three electronic photos were provided for review.Gross visual, microscopic visual, tactile and functional evaluation were performed on the returned device.The investigation is confirmed for the identified material hole issue as under microscopic evaluation pinhole was noted on the catheter body, proximal to the tissue cuff.Furthermore, the relation of identified device problem to the reported clinical condition cannot be confirmed due to lack of evidence.Therefore, the clinical conditions alleged in the complaint is inconclusive.A definitive root cause could not be determined based upon the 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: b5, d4 (expiry date: 01/2026).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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