Bardex® I.C. Foley Catheter

Description of Event or Problem

It was reported that Catheter - Silver Coated 16CH - details on packaging are Pk7670244 / D236516546s. Believes the size was a 14 instead of 16 and packaging was incorrect going to send customer over images and more details via email they can then forward on as soon as they have the extra details. Believe that our latest batch of catheters are incorrect size because of width size and aperture hole for allowing urine to exit the bladder smaller, all indicate the items being smaller but showing a 16Ch packaging and release valve. customer 16Ch have always been same diameter in the past 30 years and as shown on picture better fit/drainage.

Additional Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.This report references a US equivalent device. The US UDI equivalent for this product number is used.H11: Section A through F - The information provided by BD represents all 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.