MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER WITH BAG; URINARY DRAINAGE BAG

Model Number	A902416
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drainage port connected to the green port to drain urine out of the foley drain bag appeared to be fused together where there was just a trickle of urine allowed to drain.However, the bag could be drained if flowed back into the hard plastic square part in the front of the bag where the nozzle could be screwed off to empty the urine.Stated that the foley catheter was removed from patient and further investigation showed the bag was definitely fused together at the site of emptying into the green port to empty.When the bag was pulled on in that area to see if it would release, it tore.Customer stated that new foley placed in patient with no issues.
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 drainage port connected to the green port to drain urine out of the foley drain bag appeared to be fused together where there was just a trickle of urine allowed to drain.However, the bag could be drained if flowed back into the hard plastic square part in the front of the bag where the nozzle could be screwed off to empty the urine.Stated that the foley catheter was removed from patient and further investigation showed the bag was definitely fused together at the site of emptying into the green port to empty.When the bag was pulled on in that area to see if it would release, it tore.Customer stated that new foley placed in patient with no issues.
Additional Manufacturer Narrative
The reported event was inconclusive and unknown whether the device had met relevant specifications.The product was used for patient treatment.It was unknown whether the product had caused the reported failure.Visual evaluation of the returned photo sample noted one unopened (with original packaging), used urine meter drain bag.Visual inspection of the attached photo sample cannot be evaluated, and therefore the investigation is considered inconclusive.A potential root cause for this failure mode could be ¿incorrect assembly operation of estane glue application in the urine meter adapter and urine meter / drainage bag assembly".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: "directions for use: 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." 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 actual/suspected device was inspected.

• Brand Name: BARD® URINE METER WITH 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13965906
• Report Number: 1018233-2022-01824
• Device Sequence Number: 17187558
• Product Code: KNX
• UDI-Device Identifier: 00801741074042
• UDI-Public: (01)00801741074042
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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 Expiration Date: 11/30/2023
• Device Model Number: A902416
• Device Catalogue Number: 153204
• Device Lot Number: NGFX3372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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