C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 0602230 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562)
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Patient Problems
Extravasation (1842); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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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.The investigation of the reported event is currently underway.Medical device: expiry date: 03/2026.
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Event Description
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It was reported that approximately one month post port placement procedure via internal jugular vein, the catheter was allegedly separated and had break.It was further reported that the device allegedly had leakage at proximal end.Reportedly, patient experienced extravasation.The current status of the patient is stable.
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Manufacturer Narrative
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H10: additional information was received and the file was reassessed for reportability and determined to be reportable as serious injury.H10: 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.The investigation of the reported event is currently underway.H10: b5, d4 (expiry date: 03/2026).H11: section a through f ¿ the information provide by bd represents all 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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Event Description
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It was reported that approximately one month post port placement procedure via internal jugular vein, the catheter was allegedly separated and had break.It was further reported that the device allegedly had leakage at proximal end.Reportedly, catheter was allegedly embolized and the patient experienced extravasation.The current status of the patient is stable.
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Event Description
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It was reported that fifty five days post port placement procedure via internal jugular vein, the catheter was allegedly separated and had break.It was further reported that the device allegedly had leakage at proximal end.Reportedly, catheter was allegedly embolized and the patient experienced extravasation.The current status of the patient is stable.
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Manufacturer Narrative
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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 titanium low profile implantable port attached to a catheter were returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is confirmed for the reported fracture and fluid leak issues, as the proximal end of the attached catheter was observed to have three splits.The investigation is unconfirmed for the reported material separation issues, as no complete separation was noted on the catheter.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.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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