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

Model Number	IPN039296
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.
Event or Problem Description
Just opened 4 more of the rusch belly bags and again difficulty opening and closing the opening for urine drainage.
Additional Manufacturer Narrative
Qn# (b)(4).The historical complaints have been checked, there were similar issues received before.Since there is no relevant lot information in the complaint, we conducted a self-inspection on the latest production, the lot is 20220825.The dhr has been reviewed.The incoming, in-process and final inspection have completed, and all results meet the specification.The operators and inspectors have been effectively trained, they have no change.There is no deviation in the incoming inspection of the valve within 3 months.We randomly select and check the inventory valves, they can open and be used smoothly.After the above investigations, we have not found there is any deviation in the production and inspection processes.So we think there may be some other factors about the customer feedback, such as whether the valve is deformed, or too much force.And there is screw loose, kink and other conditions that cannot twist.In addition, we received the sample of the problem sent by the customer when the similar problem complain happened last time.Then we had a check and test on the sample.After filling the bag with simulated urine, the valve can be opened and closed 10 times normally.In the process of repeated testing, due to the structural characteristics of the product itself, we found that if single-hand operation of the valve, it is easy to twist, and not easy to operate.It is more secure to use both hands together.In order to avoid torsion when opening the valve, support the upper part first, and then open or close the valve with the other hand in the direction indicated by the arrow on the bag.Since the lack of an actual sample, we cannot determine the root cause at this present time.
Event or Problem Description
Just opened 4 more of the rusch belly bags and again difficulty opening and closing the opening for urine drainage.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15362802
• Report Number: 3011137372-2022-00175
• Device Sequence Number: 5203056
• Product Code: KNX
• UDI-Device Identifier: 14026704661777
• UDI-Public: 14026704661777
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: IPN039296
• Device Catalogue Number: B1000
• Device Lot Number: 202110915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown