C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 9808560 |
Device Problems
Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 12/11/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2021).H11: section a through f ¿ the information provided by bd represents all 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.
|
|
Event Description
|
It was reported that seven years and twelve days post a port placement via right internal jugular vein approach for the purpose of chemotherapy for uterine cancer, the two tears allegedly occurred on the catheter, one at twelve centimeter from the tip of the catheter and other just above from the stem of the port.It was further reported that the catheter fragment from the right atrium to the right ventricle.It was further reported that the catheter was allegedly difficult to be removed from the patient.Reportedly, a tear in the catheter was allegedly caused by a kink in the internal jugular vein.The current status of the patient is unknown.
|
|
Manufacturer Narrative
|
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport implantable port attached to a groshong catheter in two segments and a cath-lock were returned for sample evaluation.Functional, gross visual, tactile, dimensional and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter and segment was measured approximately 8.9cm in length.The proximal segment of the catheter was noted to be separated from the port body and had splits.Complete circumferential breaks were noted on both ends of the distal catheter segment.The edges of the complete circumferential break on the distal end of the catheter and proximal end of distal catheter segment were noted to be uneven and the surface was noted to be round and smooth on one region and granular in the other region and distal end catheter segment were noted to be jagged.Splits were noted on border of the surface.Upon the infusion and aspiration on port and on distal catheter segment was attempted and successful without issue.No leak was noted.Therefore, the investigation is confirmed for the reported fracture, deformation, material separation and identified wear and improper or incorrect procedure issue.However, the investigation is inconclusive for the reported migration, difficult to remove issue as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.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.Instructions for use reviewed: the instructions for use states that flushing volumes: when port not in use - 5 ml heparinized saline every 4 weeks.H10: b5, d4 (expiration date: 01/2021), g3, h6 (device) h11: h6 (method, result, conclusion) h11: section a through f ¿ the information provided by bd represents all 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.
|
|
Event Description
|
It was reported that seven years and twelve days post a port placement via the right internal jugular vein, two tears allegedly occurred on the catheter, one at twelve centimeter from the tip of the catheter and the other just above from the stem of the port.It was further reported that the fractured catheter fragment had allegedly migrated from the right atrium to the patient's right ventricle.Furthermore, the catheter was allegedly difficult to be removed from the patient.Moreover, a tear in the catheter was allegedly caused by a kink in the internal jugular vein.Reportedly, the port system was removed.The current status of the patient is unknown.
|
|
Search Alerts/Recalls
|
|
|