C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1829500 |
Device Problems
Suction Problem (2170); Device Tipped Over (2589); Material Protrusion/Extrusion (2979)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2023 |
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 is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 08/2023) device pending return.
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Event Description
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It was reported that sometime post port placement, the device allegedly had a suction issue.It was further reported that, the rubber reservoir compartment of port was allegedly flipped on one of the lumens, prior removal.Reportedly, the patient experienced significant pain and erythema due to extravasation into surrounding tissues which resulted from multiple times accessing one of the port lumens from this site.However, there is no further information regarding additional intervention or additional medication prescribed to treat pain, erythema and extravasation.The port was removed, and the procedure was completed replacing another device at different site.There was no reported patient injury.
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Event Description
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It was reported that sometime post port placement, the device allegedly had a suction issue.It was further reported that, the rubber reservoir compartment of port was allegedly flipped on one of the lumens, prior removal.Reportedly, the patient experienced significant pain and erythema due to extravasation into surrounding tissues which resulted from multiple times accessing one of the port lumens from this site.However, there is no further information regarding additional intervention or additional medication prescribed to treat pain, erythema and extravasation.The port was removed, and the procedure was completed replacing another device at different site.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: one powerport duo mri implantable port was returned for evaluation.Functional, gross visual, mandrel, and microscopic visual evaluations were performed.The investigation is confirmed for the identified material protrusion issue as one port septum was noted to be partially dislodged from the port body and upon infusion of the t-side port septa, a leak from the dislodged area was observed.Aspiration was attempted but was unsuccessful.However the investigation is inconclusive for the reported suction issue and device tipped over issue as the exact circumstances at the time of the reported event was unknown.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: 08/2023), g3, h6 (device).H11: h6 (method, result, conclusion).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 : see h10.
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