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

Catalog Number	154114A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 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.1.Remove protective cap from drainage tube catheter adapter and connect drainage tube to catheter.2.Position hanger on bedside rail near the foot of the bed.3.Use sheeting clip to secure drainage tube to sheet.Important: position drainage tube in a straight fashion from catheter to drainage bag.4.To empty bag: a.Remove outlet tube from housing: gently squeeze connector arms and pull tube from housing.B.Release clamp and empty bag.C.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.5.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. 1) 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.2) swab surface of site with antiseptic wipe.3) 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.4) 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.5) unkink tubing." (b)(4).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.The device was not returned.
Event or Problem Description
It was reported that when unclamping a foley catheter on a patient with a mitomycin bladder instillation, the drainage bag tubing had a hole in it, where the purple port plug was missing.This allowed mitomycin to drain onto the patient's left leg and linens.This event resulted in a chemotherapy exposure and spill, but did not cause the patient or employee harm.The drainage bag had been placed on the day of the event.Clinical statement: the mitomycin is an antineoplastic drug used for cancer.The drug is inserted into the bladder via the catheter and the catheter clamped for several hours.Then, the clamp is undone for the urine and drug to be drained.There was not any harm done to the patient or employee.The complaint is being reported for the potential of injury.(b)(6).

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: DRAINAGE BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7133042
• Report Number: 1018233-2017-06423
• Device Sequence Number: 10991093
• Product Code: KNX
• UDI-Device Identifier: 00801741029547
• UDI-Public: (01)00801741029547
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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 Catalogue Number: 154114A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/20/2017
• 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: Other
• Patient Age: 83 YR