MAUDE Adverse Event Report: TELEFLEX MEDICAL BELLY BAG; COLLECTOR, URINE, (AND ACCESSO

Model Number	IPN039296
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer called to report that the "belly bags she purchased online recently appear to have changed from what she has received in the 10+ years of use.She notes that the drain valve is much more difficult to twist and that the drain tube also seems to be a little longer".No report of patient harm or injury.Patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The customer called to report that the "belly bags she purchased online recently appear to have changed from what she has received in the 10+ years of use.She notes that the drain valve is much more difficult to twist and that the drain tube also seems to be a little longer".No report of patient harm or injury.Patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturer (hangzhou conod medical co ltd) reports: "the historical complaints within 12 months were reviewed and there are similar issues before.However, we have not found any deviation in the production and inspection processes through investigation.Check the production and inspection process of the product in recent months, they are in line with the standard.The raw materials and production process of this product have no change, and no abnormality have been found.The related in-coming inspection records of the drain valve are normal.The drain valves in the inventory are randomly selected for inspection.They can be opened, closed normally and used smoothly.Also it can be closed tightly without leak." we did not find any deviation in the production and inspection processes of this product.So we think that their customer's feedback may be related to their own use.In addition, due to the structural characteristics of the product itself, most customers will maintain a normal state of life and movement when using.If the valve is opened and closed too easily, it is very easy to cause leak.Based on the investigation and analysis, we suggest that customers should use both hands together when opening and closing the valve.Other remarks: n/a corrected data: n/a.

• Brand Name: BELLY BAG
• Common Device Name: COLLECTOR, URINE, (AND ACCESSO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16763697
• Report Number: 3011137372-2023-00101
• Device Sequence Number: 3061955
• Product Code: KNX
• UDI-Device Identifier: 14026704661777
• UDI-Public: 14026704661777
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: IPN039296
• Device Catalogue Number: B1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female