MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER; FOLEY KIT/DRAIN BAG

Model Number	A942616
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Abrasion (1689); Skin Tears (2516)
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 device was not returned.
Event or Problem Description
It was reported that the hook that hangs from the drain bag was very sharp and caused the patient's skin to tear.No medical intervention was required.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿single use only.Do not resterilize.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 or Problem Description
It was reported that the hook that hangs from the drain bag was very sharp and caused the patient's skin to tear.No medical intervention was required.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY KIT/DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8802367
• Report Number: 1018233-2019-04028
• Device Sequence Number: 18946881
• Product Code: EZC
• UDI-Device Identifier: 00801741100802
• UDI-Public: (01)00801741100802
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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
• Operator of Device: Health Professional
• Device Model Number: A942616
• Device Catalogue Number: A942616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1