MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DRAIN BAG FOLEY TRAY WITH BARDEX® ALL-SILICONE CATHETER; FOLEY CATHETER TRAY

Model Number 897516

Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

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 foley catheter tray contained two water syringes and no lube syringes.The tray should contain one of each.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿components /missing accessories¿ with a potential root cause of ¿incorrect operation¿.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: "sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not re-sterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." 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 : the device was not returned.

Event Description

It was reported that the foley catheter tray contained two water syringes and no lube syringes.The tray should contain one of each.

• Brand Name: BARD® DRAIN BAG FOLEY TRAY WITH BARDEX® ALL-SILICONE CATHETER
• Type of Device: FOLEY CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8692138
• MDR Text Key: 148270313
• Report Number: 1018233-2019-03090
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025020
• UDI-Public: (01)00801741025020
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 897516
• Device Catalogue Number: 897516
• Device Lot Number: NGCZ3296
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 07/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1