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

Model Number	119314
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
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.
Event or Problem Description
It was reported that there was no urine flow from the foley catheter to the drain bag on the day of use.Per follow up via ibc on 21apr2022, the catheter had no blockage but there was a film in the chamber of the bag.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d,f,g,h.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 there was no urine flow from the foley catheter to the drain bag on the day of use.Per follow up via ibc on 21apr2022, the catheter had no blockage but there was a film in the chamber of the bag.Per follow up via ibc on 06may2022, this is a chamber film issue not foreign material.
Additional Manufacturer Narrative
The reported event was confirmed supplier related.1sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used 1 drainage bag with inlet tube and sample port connector.Visual inspection of the sample noted attempted to flush the anti-flex drip chamber and observed a blockage.Attempted to penetrate the obstructed area with a pin and it was not easy.Also noted that the inlet tube was connected to both ends of the sample port connector and disconnected from the drainage bag.It was not reported by the user, and it is unknown if the tubing was disconnected by the user in an attempt to check for blockage in the dome.The photo sample provided shows a blockage in the anti-flex chamber.This does not meet specification per procedure which states "drainage tube must be fully inserted in anti-reflux chamber." a potential root cause for this failure mode could be ¿component cm2098 (dome), cm0535 (outlet) and cm2192 (outlet port 90 degrees) out of specification: - obstruction in internal diameter.The lot number was unknown; therefore, the device history record could not be reviewed.The labeling review was not required because labeling could not have prevented this issue.Corrections: g 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.
Event or Problem Description
It was reported that there was no urine flow from the foley catheter to the drain bag on the day of use.Per follow up via ibc on 21apr2022, the catheter had no blockage but there was a film in the chamber of the bag.Per follow up via ibc on 06may2022, this is a chamber film issue not foreign material.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: DRAIN 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: 14316356
• Report Number: 1018233-2022-03417
• Device Sequence Number: 2583421
• 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,Followup
• Report Date (Section B): 11/10/2022
• 2 Devices were Involved in the Event: 1 2

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: 119314
• Device Catalogue Number: 154004A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 11/11/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/20/2022; 11/11/2022
• 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