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

Model Number	603402
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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.The device was not returned.
Event or Problem Description
It was reported that urine would not flow into the drain bag.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "bard® latex-free center entry closed system urinary drainage bag with 3/16¿ tubing reorder 603402 contents 1 unit sterile: unless package has been opened or damaged.¿ 2000ml (approx.Vol.) control-fit¿ outlet device single use only.Do not resterilize.For urological use only.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.C.R.Bard, inc.Covington, ga 30014 1-800-526-4455 manufactured in mexico directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.1.Remove protective cap from drainage tube catheter adapter and connect drainage tube to catheter.2.Position hanger on bedside rail, using string or hooks near the foot of the bed.3.Use sheeting clip to secure drainage tube to sheet.Important: hang drainage tube in a straight fashion from bedside 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 directions for using urine sample port.5.Periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of 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.6.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.Directions for using urine sample port: 1.Kink tubing a minimum of 3 inches below the sample port until urine is visible under puncture site.2.Swab surface of puncture site with antiseptic wipe.3.Insert needle (21g or smaller) through center of puncture site.4.Aspirate desired volume of urine.5.Send specimen to laboratory.Bard is a registered trademark of c.R.Bard, inc.Or an affiliate.Control-fit is a trademark of c.R.Bard, inc.Or an affiliate.U.S.Patent no.(b)(4).
Event or Problem Description
It was reported that urine would not flow into the drain bag.

• 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: 7719181
• Report Number: 1018233-2018-03036
• Device Sequence Number: 19161445
• Product Code: KNX
• UDI-Device Identifier: 00801741029523
• UDI-Public: (01)00801741029523
• 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,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 603402
• Device Catalogue Number: 603402
• Device Lot Number: NGBV2452
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1