C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 0602830 |
Device Problems
Fracture (1260); Material Separation (1562); 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 09/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that during the port removal procedure, the catheter allegedly broke.It was further reported that the broken catheter segment remained inside the patient.Reportedly, the catheter segment was removed through the femoral access.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.
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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 bardport implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter fracture and the material separation and the identified wear and deformation issues, as a complete circumferential break was noted to the distal end of the attached catheter.The distal catheter segment was not returned.The surface of the complete circumferential break on the distal end of the attached catheter were noted to be granular and glossy.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of 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.
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Event Description
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It was reported that during the port removal procedure, the catheter allegedly broke.It was further reported that the broken catheter segment remained inside the patient.Reportedly, the catheter segment was removed through the femoral access.There was no reported patient injury.
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Search Alerts/Recalls
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