C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1618000 |
Device Problems
Fracture (1260); Material Separation (1562); Migration (4003)
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Patient Problems
Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/15/2021 |
Event Type
Injury
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Event Description
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It was reported that some time post port placement, the catheter was allegedly fractured.It was further reported that catheter was migrated into hepatic vein.Reportedly port system removed.Patient current status was unknown.
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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 record is currently being performed.The device has been returned to the manufacturer for evaluation as well as photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2019).
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Event Description
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It was reported that some time post port placement, the catheter was allegedly fractured.It was further reported that catheter was migrated into hepatic vein and embolized in the patient.Reportedly port system removed.The patient is stable now.
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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: one powerport clearvue slim implantable port attached to catheter in two segments were returned for evaluation and one electronic photo was provided for review.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter fracture and material separation issues, as a proximal segment of the catheter was noted to be attached to the port body and had a complete circumferential break near the cath-lock.A complete circumferential break was observed to the proximal end of the distal catheter segment.Both the proximal and distal edges of the proximal complete circumferential break were noted to be jagged; both break surfaces were granular.However, the investigation is inconclusive for the reported migration issue, as the exact circumstances at the time of the reported event are unknown.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.H10: d4 (expiry date: 07/2019).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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Search Alerts/Recalls
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