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

Model Number	154006
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plastic cylinder at the bottom of the drain bag released with little to no pressure.It was also stated that normally the lever holds it in but this drain bag did not have a de-tent.As per the follow up via phone on (b)(6) 2022, it was reported that the customer did not have the defective drain bag lot number, but they have the sample to return.It was stated that no medical interventions or concerns occurred concerning this event.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used drainage bag with inlet tube and sample port connector.Visual inspection of the sample noted drainage bag was filled with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the bag outlet device open and closed as intended.No root cause could be found because the reported event was unconfirmed.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.As the reported event is unconfirmed a labeling review is not required.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 the plastic cylinder at the bottom of the drain bag released with little to no pressure.It was also stated that normally the lever holds it in but this drain bag did not have a de-tent.As per the follow up via phone on 05may2022, it was reported that the customer did not have the defective drain bag lot number, but they have the sample to return.It was stated that no medical interventions or concerns occurred concerning this event.Per additional information received via sample form on 25may2022, stated that it did not stay in closed position.

• Brand Name: BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• 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: 14466650
• Report Number: 1018233-2022-03993
• Device Sequence Number: 4504709
• Product Code: KNX
• UDI-Device Identifier: 00801741029615
• UDI-Public: (01)00801741029615
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 10/19/2022

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: Lay User/Patient
• Device Model Number: 154006
• Device Catalogue Number: 154006
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 10/21/2022
• 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