H10: manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this product/lot number combination.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: one tri-funnel replacement gastrostomy tube 20f was returned for evaluation.Gross, microscopic evaluation and functional testing were performed.The investigation is confirmed for tube dislodged, migration and balloon rupture issue as a rupture to the balloon was noted starting approximately 1.5cm from the distal end of the device.Within the balloon, the inflation hub appeared double perforated.The balloon was inflated with approximately 10ml of water and immediately deflated.Water was noted exiting from the distal end of the device, as well as from the rupture on the balloon.A definitive root cause could not be determined.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.H10: d4 (expiry date: 08/2022).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.
|