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	09/21/2022
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
The customer called to report that the last several bags with this lot number have been very poor quality and basically unusable.The buckle has been changed and is extremely hard to open; she had to cut 2 bags off because the buckle would not open, the vinyl used is very thin and tears, and the tube running from the bag to the drain spout is now longer and very soft.The twist spout is also much stiffer and hard to open.She is very disappointed in the quality since manufacturing has moved.She has used the belly bag for approximately 8 years.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.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.
Event or Problem Description
The customer called to report that the last several bags with this lot number have been very poor quality and basically unusable.The buckle has been changed and is extremely hard to open; she had to cut 2 bags off because the buckle would not open, the vinyl used is very thin and tears, and the tube running from the bag to the drain spout is now longer and very soft.The twist spout is also much stiffer and hard to open.She is very disappointed in the quality since manufacturing has moved.She has used the belly bag for approximately 8 years.

• 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: 15614877
• Report Number: 3011137372-2022-00195
• Device Sequence Number: 15472086
• 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
• 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): 09/21/2022

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: 20211225
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 10/17/2022
• 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
• Patient Sex: Female