MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG; DRAIN BAG

Catalog Number	154114A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
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.
Event or Problem Description
It was reported that the patient allegedly experienced an infection and was prescribed antibiotics during use of the drain bag.The drain bag leaked from the connection between the inlet tube and the sample port connector, as a result the patient allegedly experienced an infection due the leaking bag.The drain bag was placed by the home health nurse.Gauze was wrapped around the connector where the bag was leaking until the drain bag could be changed.
Event or Problem Description
It was reported that the patient allegedly experienced an infection and was prescribed antibiotics during use of the drain bag.The drain bag leaked from the connection between the inlet tube and the sample port connector, as a result the patient allegedly experienced an infection due the leaking bag.The drain bag was placed by the home health nurse.Gauze was wrapped around the connector where the bag was leaking until the drain bag could be changed.
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 was found adequate and states the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.Remove protective cap from drainage tube catheter adapter and connect drainage tube to catheter.Position hanger on bedside rail near the foot of the bed.Use sheeting clip to secure drainage tube to sheet.Important: position drainage tube in a straight fashion from catheter to drainage bag.To empty bag: remove outlet tube from housing: gently squeeze connector arms and pull tube from housing.Release clamp and empty bag.After emptying, reclamp outlet tube and slide connector into housing until connector arms engage.Note: if specimen is required, see direction for using sample port.Periodic observations of this system should be made to ensure the urine is flowing freely.If a standing column of urine is observed, check for correct positioning or bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.Direction for use bard® ez-lok® sampling port> occlude drainage tubing a minimum of 10 cm below the sampling port by kinking the tubing until urine fills the tubing up to near (slightly above) the sampling port.Swab surface of site with antiseptic wipe.Using aseptic technique, position the needle-less syringe (slip-tip type or luer-lock type) in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port.Press the syringe and twist to lock the syringe onto the sampling port.Aspirate desired volume of urine.After sampling, detach the syringe.Ensure that the rubber stem of the sampling port has returned to its original position.Unkink tubing.".

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8004335
• Report Number: 1018233-2018-04966
• Device Sequence Number: 1387140
• Product Code: KNX
• UDI-Device Identifier: 00801741029547
• UDI-Public: (01)00801741029547
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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 Catalogue Number: 154114A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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