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

Catalog Number	154006
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
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 the drainage bag was not draining properly.They stated that it caused the external catheter to expand like a balloon and leak urine everywhere.Patient stated it was working for a few days and then stopped and they ran water through it.
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.The exact 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 "poor interfaces with connections".However, there was insufficient information to confirm this potential root cause.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "instructions for use: visually inspect the product for any defects or surface deterioration before use.If any package is open, damaged, or if you notice any defect or surface deterioration, do not use.1.Remove the protective cap from the drainage tube catheter adapter and connect the drainage tube to the catheter.2.Unhook.3.Place the hanger on the bed rail near the foot of the bed using a string or hook.4.Use the sheet clip to secure the drain tube to the sheet.Important: hang the drainage tube straight from the side of the bed to the drainage bag.5.To empty the bag: open - with your thumb on top of the device and your finger under the green lever, lift and turn counterclockwise."close - with thumb on the green lever and finger on the lever support bar, rotate the lever is clockwise.Note: if a sample is required, see directions for using the urine sample port.6.Periodic observations of this system should be made to ensure flow urine freely.If a persistent column of urine is observed, check the correct position of the bag then check for a physical obstruction.If the correct position is not determined or the physical obstruction is removed to allow free flow, the bag may need to be changed.7.After use, this product may pose a potential biological hazard, which must be handled and disposed of in accordance with accepted medical practices and applicable local, state, and federal laws and regulations.Directions for using the bard® ez-lok® sampling port: accept bard® ez-lok® sampling port luer-lock syringe or slide-tip syringe.1.Connect the drainage tube at least 3 inches below the sampling port until urine is visible below the site access.2.Wipe the site surface with a disinfectant wipe.3.Using aseptic technique, place the syringe in the center of the sampling port.Ought to the syringe is perpendicular to the surface of the sampling port (at an angle of approximately 80-100 degrees).Click press the syringe firmly and twist it gently to lock the syringe onto the sampling port.Note: improper penetration technique can cause droplet formation urine on the surface of the sampling port.Regular port monitoring is recommended take samples.4.Aspirate the required volume of urine.5.Unscrew the tubes and send the sample to the laboratory.Directions for draining the urine measuring device: if the bag is not positioned correctly, urine may bypass the meter and go directly into the bag.Replace the bag as necessary.The urine measuring device can be emptied in two ways: a.To empty it into the bag, hold the bottom of the meter and lift it up.To provide better drainage of the meters, it is recommended to raise them again.B.To empty the urine meter into the container, twist off the green part of the drain valve to the left; to close, turn the green position of the drain valve to the right.Di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some medical devices polyvinyl chloride.Dehp has been shown to produce a range of harmful effects in animals experiments, particularly liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp has been well demonstrated in experimental animals, but the ability of this compound to cause harmful effects on.Humans are controversial.There is no evidence that it is suitable for neonates, infants and pregnant women breastfeeding women exposed to dehp experience no relevant adverse effects.However, the lack of evidence the causal relationship between dehp-pvc and any disease or adverse effect does not mean there is no risk." 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 the drainage bag was not draining properly.They stated that it caused the external catheter to expand like a balloon and leak urine everywhere.Patient stated it was working for a few days and then stopped and they ran water through it.Per sample received on (b)(6) 2024, it was noted that the customer returned male external catheters 3 with material# 38303, batch# (b)(4) and 1 with material#38303 and batch# (b)(4) were returned for evaluation.Per follow up on (b)(6) 2024, it was reported that samples were returned of defective male external catheters that were not long enough.Customer states he was unable to get the catheters on because they were too short.

• Brand Name: BARD® 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: 18596091
• Report Number: 1018233-2024-00293
• Device Sequence Number: 17807533
• Product Code: KNX
• UDI-Device Identifier: 00801741029615
• UDI-Public: (01)00801741029615
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/12/2024

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: 154006
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 04/13/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 04/16/2024
• 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