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

Model Number	154004A
Medical Device Problem Codes	Restricted Flow rate (1248); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
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 urine did not flow into the drainage bag and had stopped near the drip chamber.The flow of urine allegedly stopped near the dome of the bag.
Event or Problem Description
It was reported that the urine did not flow into the drainage bag and had stopped near the drip chamber.The flow of urine allegedly stopped near the dome of the bag.Per sample evaluation from investigator via email on 18feb2022, the inlet tubing of the drain bag was noted to be kinked.
Additional Manufacturer Narrative
The reported event was confirmed supplier related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used dome bag.Visual inspection noted the inlet tubing was kinked.The dome bag was attempted to fill with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and solution was not able to enter the bag.Upon further inspection, there was a clear piece of pvc material present in between the inlet tubing and dome port.Verified dome cavity c2.This is out of specification which states, "there shall be no occlusion of the i.D.Of the inlet port, verify with pin gage".Additionally, it is possible the kinked tubing contributed to the restricted flowrate.This is out of specification which states, "any kinks in drainage tube, which reduce the i.D.More than 25% are not permitted." a potential root cause for this failure could be inspection results (measurement, testing data) not verified by iqa assignee and incorrect assembly operation of clamp/rubber band.The dhr review could not be performed without a lot number.Therefore, no additional action is required at this time.The device was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.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® 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12474601
• Report Number: 1018233-2021-05679
• Device Sequence Number: 17157890
• Product Code: KNX
• UDI-Device Identifier: 00801741029554
• UDI-Public: (01)00801741029554
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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 Model Number: 154004A
• Device Catalogue Number: 154004A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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