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.The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: it is possible that the reported leaking occurred at the tubing connection site due to deformation in the luer adaptor and the damage to the luer adaptor most likely occurred during use.One 20 g safestep infusion set was returned for evaluation.The infusion set was received with a 3-way stop-cock attached to the luer adaptor.Use residue was observed between the luer threads and the syringe/stop-cock.Functional testing revealed that the safestep infusion set was patent to infusion.When the infusion set was pressurized with water from a slip fit syringe and a luer lock syringe, no leaks were detected at the connection between the syringes and the female luer adaptor.Inspection of the luer adaptor using an iso taper gage revealed that the hub had plastically deformed, which may have contributed to the alleged leak.Gradual deformation of the luer adaptor can occur over time with continual over-tightening.Even though the taper gage indicated the luer adaptor had deformed, functional testing in the lab revealed that the connection between the luer hub and the syringes was firm and created a seal that did not leak.Microscopic inspection of the luer hub did not reveal any thread damage, stress cracking, or material discoloration.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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