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

Model Number	154004
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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 the expiry date of the drain bags have been exceeded (31jan2017).The complainant is uncertain of the exact time the bag was purchased.
Event or Problem Description
It was reported that the expiry date of the drain bags have been exceeded (31jan2017).The complainant is uncertain of the exact time the bag was purchased.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the sample noted three unopened dome bags.The evaluation of the sample indicated that the expiration date for the lot was 31jan2017.Based on a report obtained from the global distribution center, the lot was shipped to each of the distributors during 2012, signifying that the product was received by the home health agency before the products had expired.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be that the distributor sold expired products.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.".

• 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 GA 30014
• MDR Report Key: 8504814
• Report Number: 1018233-2019-01895
• Device Sequence Number: 14049434
• Product Code: KNX
• UDI-Device Identifier: 00801741029585
• UDI-Public: (01)00801741029585
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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 Expiration Date: 01/31/2017
• Device Model Number: 154004
• Device Catalogue Number: 154004
• Device Lot Number: NGWA2043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1