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

Catalog Number	153509
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three previous times before yesterday the customer would wake up and having to use the bathroom, but the attached drainage bag was not collecting urine initially until they disconnect tube from the body, using the bathroom, and then reattaching then it would work for the rest of the evening.Customer was directed by the pharmacy they purchased the item from to contact bd's complaint department for further assistance with the drainage bag issue of not being able to.
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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿tubing does not meet specification/ obstruction in tube".However, there was insufficient information to confirm this potential root cause.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: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened 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, using string or hook.3.Use sheeting clip to secure drainage tube to sheet.Important: hang drainage tube in a straight fashion from bedside to drainage bag.Ensure that the drainage bag is placed near the foot of the bed.4.If using a urine meter, it may be emptied in two ways: a.To empty into the bag, grasp the bottom of the meter and lift up.To ensure that the meter empties completely, lifting again is recommended.B.To empty urine meter into receptacle, twist green portion of drain valve to the left; to close, twist green position of the drain valve to the right.5.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.6.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.7.If bag is not positioned correctly, urine may bypass the meter and go directly to the bag.Reposition bag as necessary.Directions for using bard ez-lok® sampling port: bard ez-lok® sampling port accepts a luer-lock or slip tip syringe.1.Kink drainage tubing a minimum of 3 inches below the sampling port until urine is visible under the access site.2.Swab surface of site with antiseptic wipe.3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80-100 degree angle).Press the syringe firmly and twist gently to lock the syringe onto the sampling port.Note: improper penetration technique could cause formation of a drop of urine on the surface of the sampling port.Periodic observation of the sampling port is recommended.4.Aspirate desired volume of urine.5.Unkink tubing and send specimen to laboratory.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.¿ udi format updated with available product information per gudid as requested 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.
Event or Problem Description
It was reported that three previous times before yesterday the customer would wake up and having to use the bathroom, but the attached drainage bag was not collecting urine initially until they disconnect tube from the body, using the bathroom, and then reattaching then it would work for the rest of the evening.Customer was directed by the pharmacy they purchased the item from to contact bd's complaint department for further assistance with the drainage bag issue of not being able to.

• Brand Name: BARD® URINARY DRAINAGE BAG
• 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: 19701210
• Report Number: 1018233-2024-04082
• Device Sequence Number: 3690003
• Product Code: KNX
• UDI-Device Identifier: 00801741029608
• UDI-Public: (01)00801741029608(11)240314(17)290228(10)NGJP2181
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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 Catalogue Number: 153509
• Device Lot Number: NGJP2181
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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