C.R. BARD, INC. (BASD) -3006260740 VACCESS CT POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 7360000 |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a port placement procedure, the port allegedly leaked.There was no reported patient 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 for evaluation.The investigation of the reported event is currently underway.Device expiry date: 04/2023.
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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 vaccess ct powerport implantable port attached to a catheter was returned for evaluation.Gross visual, microscopic, tactile and functional testing were performed on the returned sample.Therefore investigation is determined to confirmed for the reported fluid leak identified catheter wear and material hole issue as wear was noted from the 15.0cm depth mark to the 13.0cm depth mark and a leak was noted exiting the cath-lock.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: d4 (expiry date: 04/2023), g3, h6 (device, method).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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Event Description
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It was reported that during a port placement procedure, the port allegedly leaked.There was no reported patient injury.
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Event Description
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It was reported that sometime post port placement procedure, the port allegedly leaked.It was further reported that the device was removed and replaced.There was no reported patient injury.
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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 vaccess ct powerport implantable port attached to a catheter was returned for evaluation.Gross visual, microscopic, tactile and functional testing were performed on the returned sample.Therefore investigation is determined to confirmed for the reported fluid leak identified catheter wear issue as wear was noted from the 15.0cm depth mark to the 13.0cm depth mark and a leak was noted exiting the cath-lock.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: d4 (expiry date: 04/2023), g3.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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