Manufacturing review: a manufacturing review cannot be performed as the batch/lot number were not provided.Investigation summary: a sample evaluation could not be performed as the samples were not returned.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include insufficient attachment mechanism between the tunneler and the catheter /incorrect tunneler/catheter interface (id oversized, too loose), clinician error; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).The investigation is inconclusive due to the fact that no sample was returned for evaluation.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
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