C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 5616000 |
Device Problems
Suction Problem (2170); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/26/2021 |
Event Type
malfunction
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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 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.(expiry date: 12/2022).
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Event Description
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It was reported that approximately two months post port placement procedure, the catheter was allegedly found to be partially looped in the internal jugular.It was further reported that blood was not returned.The procedure was completed using another device.There was no reported patient injury.
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Event Description
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It was reported that approximately two months post port placement procedure, the catheter was allegedly found to be partially looped in the internal jugular.It was further reported that blood was not returned.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation, two medical images were provided for review.The investigation is confirmed for the reported material twist/bent and suction issues as a port catheter from the right chest has looped into the ipsilateral internal jugular vein.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: 12/2022), g3, h6 (method).H11: h6 (result).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 : device not returned.
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