C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 5608062 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 03/22/2023 |
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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2023).
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Event Description
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It was reported that sometime post port placement, bleeding allegedly occurred at the insertion site.It was further reported that ice packs, pressure dressings and hemostatic agents were used but the site had still seem to be bleeding.Reportedly, patient has been provided with antiplatelet and blood thinning medication.The current status of the patient is unknown.
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Event Description
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It was reported that sometime post port placement, upon accessing, the patient allegedly experienced bleeding at the insertion site.It was further reported that ice packs, pressure dressings, and hemostatic agents were used, but the site still seemed to have bleeding.Reportedly, the patient has been provided with antiplatelet and blood thinning medication.The 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 physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.A definitive root cause could not be determined based upon the provided 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: b5, d4 (expiration date: 06/2023).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.H3 other text : device not returned.
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Search Alerts/Recalls
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