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 Problems
Bruise/Contusion (1754); Pain (1994); Swelling/ Edema (4577)
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Event Date 04/02/2023 |
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 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: 10/2024).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 not returned.
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Event Description
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It was reported that sometimes post port placement, the patient allegedly experienced pain, swelling and bruising around the septum.Reportedly pain medications and hypoallergenic dressing were provided for pain, swelling and bruising.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.One electronic photo was provided for review.The photo shows the close view of skin of the patient.Bruises like red marks and swelling were noted on the skin of the patient.However the investigation is inconclusive for the reported failure a the relation of device problem to the reported clinical condition cannot be confirmed due to lack of evidence.Therefore, the clinical conditions alleged in the complaint is inconclusive.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: 10/2024), g3, h6 (method).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.
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Event Description
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It was reported that sometimes post port placement, the patient allegedly experienced pain, swelling and bruising around the septum.Reportedly pain medications and hypoallergenic dressing were provided for pain, swelling and bruising.The current status of the patient is unknown.
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Search Alerts/Recalls
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