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
Difficult to Flush (1251); Suction Problem (2170); Material Protrusion/Extrusion (2979)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2022 |
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 device has been returned to the manufacturer.The investigation of the reported event is currently underway.(expiry date: 07/2023).
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Event Description
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It was reported that approximately two months and one day post port placement, the port allegedly had suction issue.It was further reported that the port was allegedly difficult to be flushed.Reportedly, upon removal of the port, the septum of the port was found to be allegedly dislodged.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: one powerport duo mri implantable port attached to a catheter were returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.Although sample was returned for evaluation, two electronic photo was provided for review.The investigation is confirmed for the reported material protrusion issue, as the port septum on the left was noted to be partially dislodged from the port body which was also evident in the photos provided.The investigation is inconclusive for the reported difficult to flush and suction issue, as the exact circumstances at the time of the reported event cannot be verified.A mandrel test was performed by inserting a mandrel through both port stem lumens and noting the mark on each lumen.The left port septa failed the mandrel test as the black mark was not fully inserted into each of the lumens.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: 07/2023).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 : see h10.
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Event Description
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It was reported that approximately two months and one day post port placement, the port allegedly had suction issue.It was further reported that the port was allegedly difficult to be flushed.Reportedly, upon removal of the port, the septum of the port was found to be allegedly dislodged.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 attached to a catheter were returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.Although sample was returned for evaluation, two electronic photo was provided for review.The investigation is confirmed for the reported material protrusion issue, as the port septum on the left was noted to be partially dislodged from the port body which was also evident in the photos provided.The investigation is inconclusive for the reported difficult to flush and suction issue, as the exact circumstances at the time of the reported event cannot be verified.Furthermore, mandrel test was performed by inserting a mandrel through both port stem lumens and both port septum passed the test as black mark was fully inserted into the lumens.A definitive root cause could not be determined based upon the provided 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: (expiry date: 07/2023).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.
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Event Description
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It was reported that approximately two months and one day post port placement, the port allegedly had suction issue.It was further reported that the port was allegedly difficult to be flushed.Reportedly, upon removal of the port, the septum of the port was found to be allegedly dislodged.There was no reported patient injury.
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Search Alerts/Recalls
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