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); Laceration(s) (1946)
Type of Reportable Event	Serious Injury
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 to be cut and received 4 stitches to their leg.
Additional Manufacturer Narrative
The reported event could not be confirmed.Visual inspection noted two unused meter bags were received with the inlet tubing, sample port connectors and foley catheters with the tes intact.Visual evaluation noted the clear hangers appeared normal and rounded.No evidence of blood or damage to the hangers.Two non-original product samples were returned, therefore the results of the investigation were inconclusive.Although the reported event could not be confirmed, a potential root cause for this failure could be brittle material - inappropriate material choice.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: "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." correction: d10, h3 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.
Event or Problem Description
It was reported that the hook that hangs from the drain bag was very sharp and caused the patient to be cut and received 4 stitches to their leg.

• 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: 8802365
• Report Number: 1018233-2019-04017
• Device Sequence Number: 18914009
• 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): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention