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

Model Number	IPN039296
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint history has been reviewed.Since there is no relevant lot information provided a self-inspection on the latest production was done.The lot is 20220928.The device history record was reviewed.The incoming, in-process and final inspection have been completed and all results meet the specifications.The operators and inspectors have been effectively trained without changes.There is no deviation in the incoming inspection of the valve within three months.The inventory is randomly selected and checked and they opened smoothly.An investigation of the assembly process was done to identify risks and training was conducted for operators.In addition, a sample was received from the customer with a similar problem in the past.On investigation, we found that with single-hand operation of the valve it was easy to twist and not easy to operate.It is more secure when both hands are used 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.
Event or Problem Description
It was reported that the patient states he is having an issue with his belly bags leaking and difficulty opening the drain valve.He stated that one lasted for 2 days, one for 1 day and the last one lasted only 6 hours.There was no reported injury.
Event or Problem Description
It was reported that the patient states he is having an issue with his belly bags leaking and difficulty opening the drain valve.He stated that one lasted for 2 days, one for 1 day and the last one lasted only 6 hours.There was no reported injury.
Additional Manufacturer Narrative
(b)(4).Corrected section h.6 (adverse event problem): imdrf annex code changed from c19 to c20.Please make a note of it.
Event or Problem Description
It was reported that the patient states he is having an issue with his belly bags leaking and difficulty opening the drain valve.He stated that one lasted for 2 days, one for 1 day and the last one lasted only 6 hours.There was no reported injury.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for evaluation.The supplier was contacted and provided the following: "1.The historical complaints have been checked, there were similar issues received before (no.(b)(4)).2.Since there is no relevant lot information in the complaint, we conducted a self-inspection on the latest production, the lot is 20220928.Check the dhr records.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.3.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.4.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.5.Check the complaint lists for 2022, and we noted that there have been similar issues before this.In the investigation of some of the above product defects and defects caused by use, we also check the assembly site of the valve.The valve is connected with the draining tube by glue bonding.We learned from the inquiry of the operator and the person in charge of production that, if the draining tube is dipped in too much glue during the assembly process, the glue may flow down from the inner wall of the valve, reach the top of the core, and stick to the herringbone fork of the valve shell, resulting in that the valve cannot be opened normally.Therefore, in the subsequent work, we have identified the risk, and also conducted effective training for operators.In addition, we will also conduct self-inspection, which can effectively check the abnormality of valve caused by such assembly." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15692367
• Report Number: 3011137372-2022-00204
• Device Sequence Number: 7385138
• Product Code: KNX
• UDI-Device Identifier: 14026704661777
• UDI-Public: 14026704661777
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 10/12/2022

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 Expiration Date: 04/13/2024
• Device Model Number: IPN039296
• Device Catalogue Number: B1000
• Device Lot Number: 74D2101512
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 10/31/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 12/02/2022; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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
• Patient Sex: Unknown