C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 7707540J |
Device Problems
Fracture (1260); Loose or Intermittent Connection (1371); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified in has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f are identified.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 for evaluation.The investigation of the reported event is currently underway.
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Event Description
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It was reported that during a port placement procedure, the connection between the introducer needle and the syringe was poor.It was further reported that the air allegedly leaked while applying negative pressure.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f are identified in d2 and g4.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: two syringes and one introducer needle were returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed on the returned device.The investigation is confirmed for the identified fracture issue as multiple cracks were noted on the hub of the introducer needle.Further during functional evaluation, the introducer needle was able to be connected to both the syringes.Fluid leak was noted through the cracks upon infusion and partial aspiration was noted on one syringe and complete aspiration was noted on another syringe.However, the investigation is inconclusive for the reported loose or intermittent connection and air/gas in device issues as the exact circumstances at the time of the reported event cannot be verified.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: 01/2024).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 during a port placement procedure, the connection between the introducer needle and the syringe was poor.It was further reported that the air allegedly leaked while applying negative pressure.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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