C.R. BARD, INC. (BASD) -3006260740 APHERESIS PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number A710962 |
Device Problems
Reflux within Device (1522); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that sometime post port placement, the port allegedly bled through the catheter.However, there is no information regarding treatment provided for bleeding.There was no reported patient injury.
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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 records was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 11/2022).
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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.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 (expiration date: 11/2022), g3, h6 (method).H11: h6 (device).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 sometime post port placement, the port allegedly bled through the catheter.However, there is no information regarding treatment provided for bleeding.There was no reported patient injury.
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Search Alerts/Recalls
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