C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 9808560 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that seven months and twenty four days post port placement, when the catheter was removed, the stylet remained in the catheter.Reportedly port was removed.There was no reported patient injury.
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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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
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Manufacturer Narrative
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H10: this supplemental mdr is being submitted to report that mfr rpt# was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr rpt# 3006260740-2022-02513.H10: g3.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 seven months and twenty four days post port placement, when the catheter was removed, the stylet remained in the catheter.Reportedly port was removed.There was no reported patient injury.
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Search Alerts/Recalls
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