C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 9808560 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 through the right subclavian vein, the port allegedly leaked subcutaneously which was found upon computed tomographic examination.It was further reported that the patient experienced swelling.There was no additional intervention or medication prescribed for the swelling.There was no reported patient injury.
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Event Description
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It was reported that during a port placement procedure through the right subclavian vein, the port allegedly leaked subcutaneously which was found upon computed tomographic examination.It was further reported that the patient experienced swelling.There was no additional intervention or medication prescribed for the swelling.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter leak and identified fracture, deformation and wear issues as a partial circumferential break was noted on the catheter approximately 0.4cm from the distal end of the cath-lock.The edges of the partial circumferential break on the attached catheter were noted to be round and smooth.The surface was noted to be granular.Upon infusion, a leak was noted from the partial circumferential break.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.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.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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Search Alerts/Recalls
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