MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG; DRAIN BAG (322416A)

Model Number	154005A
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 retuned.
Event or Problem Description
It was reported that the drain bag wouldn¿t drain.The customer reportedly attempted to reposition, flush, etc., and ended up having to change it out.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿clip breaks off¿ with a potential root cause of ¿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: "directions for use: 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: open - with thumb on top of device and finger under green lever, lift and rotate counterclockwise.Close - with thumb on green lever and finger on lever support bar, rotate lever clockwise.Note: if specimen is required, see directions for using urine 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 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." 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 retuned.
Event or Problem Description
It was reported that the drain bag wouldn¿t drain.The customer reportedly attempted to reposition, flush, etc., and ended up having to change it out.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: DRAIN BAG (322416A)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9853530
• Report Number: 1018233-2020-01938
• Device Sequence Number: 3435549
• Product Code: KNX
• UDI-Device Identifier: 00801741029561
• UDI-Public: (01)00801741029561
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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: 154005A
• Device Catalogue Number: 154005A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1