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	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: customer reported the drain valves are frozen, way too stiff, cannot be opened.There was no injury reported.
Additional Manufacturer Narrative
(b)(4).Since we did not find the product batch information in this complaint, we conducted a self-inspection on the recently produced products, and the batch number is 20220928.Check the dhr records.The incoming, in-process and final inspection have completed, and all results meet the specification.The raw materials and production process of the product are unchanged.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.According to the investigation of similar problems of such products in the past, it may be that the screw valve is abnormally bonded during the assembly process, resulting in the inconvenience of opening and closing.We have identified this risk in the daily operation and can effectively troubleshoot this situation.In addition, we received the sample of the problem sent by the customer when the similar problem complaint happened last time.And 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 arow on the bag.We speculate that the screw valve is difficult to unscrew at present, which may include the following two situations.The screw valve cannot be opened due to abnormal adhesion caused by the assembly process.Inconvenient operation during use, resulting in twisting of the screw valve tube.We will continue to monitor the follow-up development of such complaints.The above corrective and preventive measures are implemented when the same problem occurs in the previous product, and no other measures are implemented.
Event or Problem Description
Reported issue: customer reported the drain valves are frozen, way too stiff, cannot be opened.There was no injury reported.

• 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: 15827246
• Report Number: 3011137372-2022-00220
• Device Sequence Number: 14991771
• Product Code: KNX
• UDI-Device Identifier: 14026704661777
• UDI-Public: 14026704661777
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: UNKNOWN
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown