C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806060 |
Device Problems
Fracture (1260); Deformation Due to Compressive Stress (2889)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4: (expiry date: 08/2023).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 five months twenty-seven days post a port placement in right internal jugular vein, the patient's chest wall was allegedly found to be bulged out a large bag after flushing.It was further reported that the catheter was found to be creased under radiograph imaging.Upon port removal, catheter was allegedly found to be broken.Current status of the patient is unknown.
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Manufacturer Narrative
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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: the sample was not returned for evaluation.One electronic photo was provided for review.The photo shows the catheter placed in a patient body and the clinician holding the catheter.A longitudinal split was noted on the center of the catheter and the fractured area was noted to be deformed.Therefore, the investigation is confirmed for the reported fracture and deformation issue.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: (expiration date: 08/2023).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 five months and twenty-seven days post a port placement via the right internal jugular vein, the patient's chest wall was allegedly found to be bulged out a large bag after flushing.It was further reported that the catheter was found to be creased under radiograph imaging.Furthermore, upon port removal, catheter was allegedly found to be broken.The current status of the patient is unknown.
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