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

Model Number	IPN039296
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that while in use, the belly bag is "leaking from where the inlet tube meets the bag".Additional information received states that there was no patient harm or injury, or medical intervention required.The issue was resolved by changing the bag.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4) the sample was not returned to the manufacturer for investigation.The manufacturer reported: "since we did not receive the actual sample, we analyzed the samples with similar problems received in the past and the actual use process of the product.The position of the dome is connected with the connector, and this position is indeed susceptible to some external forces in the actual use (ie.Pulling during the assembly of the catheter, some turning and pulling during the continuous wear of it or some external force).The root cause is speculated to may be due to some external factors in the actual use process.However, without the sample the actual root cause was undetermined.A device history record review was performed, and no relevant findings were identified." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use, the belly bag is "leaking from where the inlet tube meets the bag".Additional information received states that there was no patient harm or injury, or medical intervention required.The issue was resolved by changing the bag.The patient status is reported as "fine".

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17079671
• Report Number: 3011137372-2023-00161
• Device Sequence Number: 11309766
• Product Code: KNX
• UDI-Device Identifier: 14026704661777
• UDI-Public: 14026704661777
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: 05/19/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 01/22/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown