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

Catalog Number	150832
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 product was packaged in a different outer packaging and labelling was functioning differently than the original product.As per the follow-up information received 08aug2024, the patient's wife felt that the product changed as the packaging was different.The issue with the product was that the wife (carer) felt that the bardia bag in the new package had a weaker section at the top of the port that made the bag kink at night.As a result, the carer felt exhausted as they were up every 2 hours during the night adjusting the bag to encourage drainage when kinked.They knew that the carer had spoken to 2 representatives about this issue, who had reinforced to the client/carer that the product had not changed despite the change in packaging.The issue was with all the new packaged barida products.The carer continues to use the product despite being offered alternatives as they feel bardia is the best brand.They had no issues with bags prior to new packaging.
Event or Problem Description
It was reported that the product was packaged in a different outer packaging and labelling was functioning differently than the original product.As per the follow-up information received 08 aug 2024, the patient's wife felt that the product changed as the packaging was different.The issue with the product was that the wife (carer) felt that the bardia bag in the new package had a weaker section at the top of the port that made the bag kink at night.As a result, the carer felt exhausted as they were up every 2 hours during the night adjusting the bag to encourage drainage when kinked.They knew that the carer had spoken to 2 representatives about this issue, who had reinforced to the client/carer that the product had not changed despite the change in packaging.The issue was with all the new packaged barida products.The carer continues to use the product despite being offered alternatives as they feel bardia is the best brand.They had no issues with bags prior to new packaging.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.This report references a us equivalent device.The us udi equivalent for this product number is used.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.

• Brand Name: LEG BAG
• Common Device Name: LEG 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20085241
• Report Number: 1018233-2024-05242
• Device Sequence Number: 15343970
• Product Code: FAQ
• UDI-Device Identifier: 00801741050886
• UDI-Public: (01)00801741050886(17)280930(10)NGHX4240
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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 Catalogue Number: 150832
• Device Lot Number: NGHX4240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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