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

Catalog Number	154114A
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
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.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 twice in the last week a foley drainage bag would not drain when the nurse unclamped the foley to drain the bag.The nurse attempted to flush the green drainage tube where the clamp lied, but it would not flush.It was discovered in two instances that the drainage bag was sealed to itself, thus not draining.When the nurse tried to peel the drainage bag sides away from each other, the bag sprung a leak and leaked urine.(lot# unk - 154114a) lot# nghv0244 - 153204).
Event or Problem Description
It was reported that twice in the last week a foley drainage bag would not drain when the nurse unclamped the foley to drain the bag.The nurse attempted to flush the green drainage tube where the clamp lied, but it would not flush.It was discovered in two instances that the drainage bag was sealed to itself, thus not draining.When the nurse tried to peel the drainage bag sides away from each other, the bag sprung a leak and leaked urine.(lot# unk - 154114a) (lot# nghv0244 - 153204).
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.A root cause could not be definitively identified, based on the risk documentation review, the potential root cause for this type of failure could be " tooling out of specification ".However, there was insufficient information to confirm this potential root cause.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: "warning: 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 use: visually inspect the product for any imperfections or surface deterioration prior to use.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 clp to secure drainage tube to sheet, important: position drainage tube in a straight fashion from catheter to drainage bag.4.To empty bag: a.Remove outlet tube from engage housing: gently squeeze connector arms and pu tube from housing.Control-fittm connector disengage b.Release clamp and empty bag.C.After emptying, redamp outlet tube and side 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 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.Its correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.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." 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.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: BARD® 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: 19285351
• Report Number: 1018233-2024-02645
• Device Sequence Number: 18047291
• Product Code: KNX
• UDI-Device Identifier: 00801741029547
• UDI-Public: (01)00801741029547
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: Health Professional
• Device Catalogue Number: 154114A
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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