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
Degraded (1153); Fracture (1260); Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Event Description
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It was reported that approximately five years post port placement procedure and when the port system was removed, the surface of the catheter allegedly peeled off in the patient¿s body.The part of the surface of the catheter remains in the patient¿s body.There was no reported patient injury.
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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.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.The investigation of the reported event is currently underway.
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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: one bard ti/lp implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported peeled and degraded issues as the catheter was noted to be degraded from the 10.0cm depth mark to the 13.0cm depth mark and the catheter material appeared to be peeled off in the same region.Further, the investigation is also confirmed for the identified fracture issue as a longitudinal split was noted to the catheter approximately 6.7cm from the distal end of the cath-lock.During functional evaluation, a leak was noted from the longitudinal split upon infusion.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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Event Description
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It was reported that approximately five years post port placement procedure and when the port system was removed, the surface of the catheter allegedly degraded and peeled off in the patient¿s body.The part of the surface of the catheter remains in the patient¿s body.There was no reported patient injury.
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Search Alerts/Recalls
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