The catalog number identified has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified.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.The investigation of the reported event is currently underway.(expiry date: 05/2022).
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this lot number and the lot met all release criteria.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: one powerport mri isp, one catheter, one flushing connector, one introducer needle, one right-angle non-coring needle, one vein pick, one catheter lock, one guidewire in a guidewire hoop, and one safety infusion set were returned for evaluation.The investigation is confirmed for the reported fracture and air/gas in device issues as cracks were noted on the hub of the introducer needle.Further during functional evaluation leak was noted from the cracks upon infusion and aspiration, air filled the syringe upon aspiration.Based upon the available information, the definitive root cause for this event is unknown.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: 05/2022), g3, h6 (device: a1415).H11: h6 (device, method, result, conclusion).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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