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

Model Number	154114A
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
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.The device was not returned.
Event or Problem Description
It was reported that the urinary drainage bag had a hard time irrigating bladders postoperatively and clots are getting caught in the tubing.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿obstruction in tube".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "direction for use: visually inspect the product for any imperfection or surface deterioration prior to use.If 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 the catheter.2.Position hanger on bedside rail near the foot of the bed.3.Use sheeting slip to secure drainage tube sheet.Important : position drainage tube in a straight fashion from catheter to drainage bag.4.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.5.Periodic observation 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 the for physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed." 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 urinary drainage bag had a hard time irrigating bladders postoperatively and clots are getting caught in the tubing.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: 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: 16529129
• Report Number: 1018233-2023-01677
• Device Sequence Number: 14108789
• Product Code: KNX
• UDI-Device Identifier: 00801741029547
• UDI-Public: (01)00801741029547
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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 Model Number: 154114A
• Device Catalogue Number: 154114A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/18/2023
• 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