The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
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The reported event confirmed, cause unknown.The used temporary pacing electrode with attached luer syringe was returned without the original packaging.Though a specific cause cannot be determined, a potential root cause for this event could be, "pulling distal wire to taut at mp5898 (assemble electrodes proximal/distal)".The device was used for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires." "inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged." "visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." corrections: d,f,h h11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.
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