MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX)

Model Number 0165SI14

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Premature Labor (2465); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the inflation valve print was unclear.

Event Description

It was reported that the inflation valve print was unclear.

Manufacturer Narrative

The reported issue was confirmed.The device was returned for evaluation.Visual inspection found the information printed on the cap of the catheter was not clear and smeared.No other components were returned together with this sample.Temper evidence seal also have been remove and not returned together with the sample.Unable to determine how and when the problem occurred.This occurred post manufacturing process.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿[shape, configuration and principles] bard®i.C.Silver foley tray b consists of a balloon catheter, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, tweezers, waterproof sheet, gauze pads, cotton balls and vinyl gloves.There are several types of closed drainage bags.The bag included in the tray will depend on the product. available in sizes 8 to 24 every 2fr" 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.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8940322
• MDR Text Key: 185983306
• Report Number: 1018233-2019-05171
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Device Lot Number: MYDN1416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1