C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 5608062 |
Device Problems
Improper or Incorrect Procedure or Method (2017); 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 09/29/2023 |
Event Type
malfunction
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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 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.H10: d4 (expiration date: 01/2020) 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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Event Description
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It was reported that sometime post a port placement, the patient allegedly had intermittent pain in the port area of her right chest.Furthermore, there is no information provided regarding additional medical intervention or medication prescribed to treat the pain.There was no reported patient injury.
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Event Description
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It was reported that sometime post a port placement, the patient allegedly had intermittent pain in the port area of the right chest.Reportedly, the patient was provided with a nonsteroidal anti-inflammatory drug to treat pain.There was no reported patient injury.
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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, the clinical conditions alleged in the complaint cannot be confirmed.However, the investigation is confirmed for the identified improper procedure or method used issue as the port was not flushed regularly as per instructions for use.The definitive root cause for the reported pain issue could not be determined based upon the provided information, user error could have contributed to the identified improper procedure or method used issue.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.The instructions for use states that: saline lock procedure for groshong* catheters: when port not in use - 5 ml sterile normal saline every 4 weeks.H10: (expiration date: 01/2020).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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