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

Model Number	300316A
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
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 upon opening the package of the foley tray, it was noted that the sterile water syringe was short 6ml.
Additional Manufacturer Narrative
The reported issue was confirmed as cause unknown.Per the photo sample received, the reported issue could be confirmed that the sterile water syringe was short 6ml.No physical sample was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "- contents: string hanger, attached sheeting clip, underpad, fenestrated drape, gloves, 3 antiseptic swab sticks, 10cc lubricating jelly syringe, prefilled 10cc syringe of sterile water, specimen container with cap and label, hand sanitizer, cleansing wipe.- do not use if package is damaged.".
Event or Problem Description
It was reported that upon opening the package of the foley tray, it was noted that the sterile water syringe was short 6ml.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY CATHETER TRAY
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7584500
• Report Number: 1018233-2018-02138
• Device Sequence Number: 178530
• Product Code: MJC
• UDI-Device Identifier: 00801741024344
• UDI-Public: (01)00801741024344
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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): 06/11/2018

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 Model Number: 300316A
• Device Catalogue Number: 300316A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1