Information was received indicating that a smiths medical cadd administration set was noted to have the line threaded through the side clamp and was unable to be rectified.The reporter indicated that the needle and introducer were inspected prior to insertion, needle was inserted into patient's lower back, then the needle was slowly withdrawn then a sudden loss of resistance was felt and only half of needle came out of the patient, other half broke off inside patients back on removal.The reporter indicated that neurologist came in and performed operation to remove remaining needle.No further adverse effects were reported.
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Other, other text: one sample was received in used condition.The product itself comes out from smh manufacturing without a needle, it was inspected just to confirm it does not have one.No manufacturing related solvent bonds were found inaccurately nor assemblies.A review of documentation and manufacturing processes found no defects in either.There was no fault found with the returned sample.
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