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

Model Number	897516
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the iodine pack leaked inside of the tray.
Additional Manufacturer Narrative
The reported issue (the iodine pack had leaked inside of the tray), was confirmed, as unknown.During the visual evaluation was found the iodine leaked.The swab stick damaged the iodine package.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿contents: this preconnected closed system foley tray includes: bardex® all-silicone foley catheter, statlock® foley stabilization device, tamper evident tubing junction seal, ez-lok® needleless urine sample port, 2000ml (approx.Vol.) collection bag, anti-reflux chamber, control-fit¿ outlet device.String hanger, attached sheeting clip, underpad, fenestrated drape, latex-free gloves, 3 antiseptic swab sticks, 10cc lubricating jelly syringe, prefilled 10cc syringe of sterile water, specimen container with cap and label, hand sanitizer, castile soap towelettes sterile unless package is open or damaged, except for the hand sanitizer and castile soap towelettes which are not terminally sterilized." (b)(4).
Event or Problem Description
It was reported that the iodine pack leaked inside of the tray.

• Brand Name: BARD® DRAIN BAG FOLEY TRAY WITH BARDEX® ALL-SILICONE CATHETER
• Common Device Name: SILICONE CATHETER FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6841787
• Report Number: 1018233-2017-04597
• Device Sequence Number: 13627989
• Product Code: EZL
• UDI-Device Identifier: 00801741025020
• UDI-Public: (01)00801741025020
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 897516
• Device Catalogue Number: 897516
• Device Lot Number: NGBR2218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1