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

Model Number	802001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Urinary Tract Infection (2120)
Date of Event	06/12/2023
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.H11: section a through f - the information provided by bd represents all 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 returned.
Event or Problem Description
It was reported that drain bag leaked out where the tube connected to the bag.No additional injury occurred due to malfunction.Changed bag once a month.Per follow up via phone on 12jun2023, it was reported that two bags leaked after using each for only one day.The customer was currently dealing with a bladder infection and was prescribed pyridium to help alleviate the urinary tract infection.The antibiotic had caused the urine to smell too strong, and the bags were disposed of after they leaked.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to ¿materials of construction are not biocompatible¿.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 were found adequate and state the following: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Directions for use: wash hands.Remove protective cap from drainage tube and connect drainage tube adapter to catheter.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.Check that urine is draining into bag.To empty bag: remove outlet tube from housing.Release clamp and empty bag.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.Wash hands.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: kink tubing a minimum of 3 inches below sample sleeve until urine is under sample site.Swab surface of puncture site with antiseptic wipe.Insert needle (21g or smaller) through center of puncture site.Be careful to avoid puncturing opposite side of sample sleeve.Remove desired volume of urine.Release kink to permit flow to drainage bag.Send specimen to laboratory." h11: section a through f - the information provided by bd represents all 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 returned.
Event or Problem Description
It was reported that drain bag leaked out where the tube connected to the bag.No additional injury occurred due to malfunction.Changed bag once a month.Per follow up via phone on 12jun2023, it was reported that two bags leaked after using each for only one day.The customer was currently dealing with a bladder infection and was prescribed pyridium to help alleviate the urinary tract infection.The antibiotic had caused the urine to smell too strong, and the bags were disposed of after they leaked.Per follow up via phone on 11aug2023, it was reported that customer was in need of replacement units for the drain bags they disposed back in june.The customer was advised to go through their current product supplier, tri-state supplies, llc in lincoln, nebraska.Customer would coordinate with them to receive replacement units.

• Brand Name: BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Common Device Name: URINARY DRAINAGE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17218480
• Report Number: 1018233-2023-04773
• Device Sequence Number: 14199413
• Product Code: KNX
• UDI-Device Identifier: 00801741040740
• UDI-Public: (01)00801741040740
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2025
• Device Model Number: 802001
• Device Catalogue Number: 802001
• Device Lot Number: NGHN0322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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; Required Intervention
• Patient Sex: Unknown