C.R. BARD, INC. (BASD) -3006260740 POWERFLOW APHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number A710962 |
Device Problems
Restricted Flow rate (1248); Suction Problem (2170); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not 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.
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Event Description
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It was reported that some time post port placement on right lateral side of the chest, the port allegedly had slow flow rate while accessing.It was further reported that the port allegedly had difficulty on withdrawing with a syringe.Reportedly, patient did not get the full treatment prescription.There was no reported patient injury.
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Event Description
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It was reported approximately one month post port placement on right lateral side of the chest, the port allegedly had slow flow rate while accessing.It was further reported that the port allegedly had difficulty on withdrawing with a syringe.Reportedly, patient did not get the full treatment prescription.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the third complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: the investigation is inconclusive for the reported suction, obstruction of flow, restricted flow issue, as the device was not returned for evaluation.A definitive root cause could not be determined based upon the 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: 12/2021).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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