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

Model Number	IPN039296
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: just had another belly bag leak in the first week.This time it was a faulty valve.
Event or Problem Description
Reported issue: just had another belly bag leak in the first week.This time it was a faulty valve.
Additional Manufacturer Narrative
Qn# (b)(4).Since we did not get the lot information of the product in the complaint, we conducted a self-check on the recent production, whose product lot number is 20221205.The device history record was checked.The incoming, in-process and final inspection have completed, all results meet the specification.There was no deviation reported.The retention sample of this lot was tested, and no leak was found.According to the analysis of the complaint, the customer's feedback should be the problem of the drain valve.The incoming inspection within 3 months of this valve shows no abnormality.We randomly checked the inventory of valves for inspection.The valves can be effectively used, and no fault was found.When we checked the list of complaints for 2-22, we noticed that there were many such complaints, most of which were easy to loosen and inconvenient to use.Therefore, in addition to routine inspection of defects that may be caused by the production process and use process of some products, we have also carried out risk identification for the assembly of valves in daily operations, which can effectively troubleshoot such anomalies, and the relevant operators have been effectively trained.We speculate that the current abnormal valve is still due to its assembly and use.Judging from the trend of complai nts after risk identification and relevant measures ate implemented, we think the feedback from the customer is still related to the actual use of products.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16038371
• Report Number: 3011137372-2022-00251
• Device Sequence Number: 12131784
• Product Code: KNX
• UDI-Device Identifier: 14026704661777
• UDI-Public: 14026704661777
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/27/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Male