C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0606150J |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, groshong single-lumen, 8f are identified in common device name and pma/510k.As the lot number for the device was not provided, a review of the device history records could not be 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.
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Event Description
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It was reported that after the port placement procedure, sheath was put into the water to test, it was found that the air was allegedly mixed.It was further reported that the peel away sheath allegedly had split at the base.There was no patient contact.
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Event Description
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It was reported that after the port placement procedure, sheath was put into the water to test, it was found that the air was allegedly mixed.There was no patient contact.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, groshong single-lumen, 8f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: three samples were returned for evaluation.Upon review only one sample was reported defective.Functional, gross visual and microscopic visual evaluations were performed.Although the sample was returned for evaluation, three electronic photos were provided for review.The investigation is confirmed for the identified fracture issue, as a small hole, was noted between the center of the t-handle.The investigation is unconfirmed for the reported fluid leak issue, as no leaks were noted coming out of what appeared like an open hole.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.
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Search Alerts/Recalls
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