H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport mri isp implantable port, one catheter, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, one cath-lock, one syringe, one guidewire, a guidewire hoop, one 8.0fr peel-apart sheath and vessel dilator, and one tunneler were returned for evaluation.Gross visual evaluation was performed on the returned devices and no visual anomalies related to device fracture was noticed.Therefore, the investigation is unconfirmed for the reported defective device and fracture issues.The definitive root cause could not be determined based upon available information.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.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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