MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER; DRAIN BAG

Model Number	802001
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the leg bags were leaking.As per follow up via phone on (b)(6) 2022, it was reported that the drain bag leaked at the inlet tube, and the clamp was not staying closed and leaking.The customer had to buy pieces from home depot to keep it closed.Also stated that urine was backing up from the anti-reflux valve.Customers also have a new one currently leaking from the top and also having an issue with the clamp staying closed.The customer stated they also had a bladder infection every month for a year and had been prescribed various antibiotics.
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 leg bags were leaking.As per follow up via phone on 15oct2022, it was reported that the drain bag leaked at the inlet tube, and the clamp was not staying closed and leaking.The customer had to buy pieces from home depot to keep it closed.Also stated that urine was backing up from the anti-reflux valve.Customers also have a new one currently leaking from the top and also having an issue with the clamp staying closed.The customer stated they also had a bladder infection every month for a year and had been prescribed various antibiotics.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿poor interfaces with connections¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.Wash hands.2.Remove protective cap from drainage tube and connect drainage tube adapter to catheter.3.Fasten drainage bag to bedframe near the foot of the bed.Do not allow bag to touch floor.Important: hang drainage tube in a straight fashion from bedside to drainage bag.If drainage bag is placed even with patient¿s hip, coil tubing alongside patient.Tubing should be draped over patient¿s leg.4.Check that urine is draining into bag.5.To empty bag: a.Remove outlet tube from housing.B.Release clamp and empty bag.C.When bag is empty, return clamp to closed position and replace tube in housing.Note: if specimen is required, see directions for obtaining urine sample.6.Wash hands.7.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 obtaining urine sample: 1.Kink tubing a minimum of 3 inches below sample sleeve until urine is under sample site.2.Swab surface of puncture site with antiseptic wipe.3.Insert needle (21g or smaller) through center of puncture site.Be careful to avoid puncturing opposite side of sample sleeve.4.Remove desired volume of urine.Release kink to permit flow to drainage bag.5.Send specimen to laboratory." h11: section a through f - 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.

• Brand Name: BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15679404
• Report Number: 1018233-2022-08135
• Device Sequence Number: 5983069
• Product Code: KNX
• UDI-Device Identifier: 00801741040740
• UDI-Public: (01)00801741040740
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 802001
• Device Catalogue Number: 802001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown