C.R. BARD, INC. (BASD) -3006260740 HICKMAN PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603880C |
Device Problems
Difficult to Insert (1316); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a port placement procedure in the right internal jugular vein, the vascular sheath was allegedly unable to be inserted during the operation.It was further reported that the sheath was allegedly difficult to remove, and the sheath was found to be deformed upon removal.There was no reported patient injury.
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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 m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified in d2 and g4.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.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025).H11: section a through f ¿ the information provide 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 : device pending return.
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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 m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified in d2 and g4.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 bardport mri implantable port kit was received for evaluation and one photo was provided for review.Visual and microscopic evaluations were performed.The distal tip of dilator was noted to be damaged.Therefore, the reported material deformation issue is unconfirmed as the specific damage such as deformation due to compressive stress issue was identified and confirmed during investigation and the photo review also confirms the same.However, the reported difficult to insert and difficult to remove issues is inconclusive as the exact circumstance at the time of the event reported was unknown.The definitive root cause could not be determined based upon available information labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2025), 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.
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Event Description
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It was reported that during a port placement procedure in the right internal jugular vein, the vascular sheath was allegedly unable to be inserted during the operation.It was further reported that the sheath was allegedly difficult to remove, and the sheath was found to be deformed upon removal.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 in the right internal jugular vein, the vascular sheath was allegedly unable to be inserted during the operation.It was further reported that the sheath was allegedly difficult to remove, and the sheath was found to be deformed upon removal.There was no reported patient injury.
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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 m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified in d2 and g4.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 bardport mri implantable port kit was received for evaluation and two photos were provided for review.Visual and microscopic evaluations were performed.The distal tip of dilator was noted to be damaged.Therefore, the reported material deformation issue is unconfirmed as the specific damage such as deformation due to compressive stress issue was identified and confirmed during investigation and the photo review also confirms the same.However, the reported difficult to insert and difficult to remove issues is inconclusive as the exact circumstance at the time of the event reported was unknown.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2025).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.
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