MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD 2W 5ML SIL STR H 14; CATHETER, UROLOGICAL

Model Number	IPN050511
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A foley catheter was installed in the pavilion on (b)(6) 2022 in a patient undergoing cesarean section.On day 30, when trying to remove the catheter, the cuff could not be deflated, only 9 cc of serum came out (cuff inflated with 10 cc).Catheter can be removed.
Additional Manufacturer Narrative
Qn#(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and 100% passed inspection.An actual sample was returned for investigation.Visual examination on the catheter showed that there was no sign of kinking, clamp mark or collapse lumen observed throughout the shaft.The catheter then was inflated with 10ml of water using a luer tip syringe.The balloon can be inflated as normal.Deflation of the balloon by connecting empty luer tip syringe barrel to the valve showed that the balloon can be fully deflated.In summary, based on the investigation, the balloon can be deflated as normal.The balloon also can be fully inflated during inflation test.Reviewing the manufacturing process, no potential cause could have contributed to the problem.All products were subjected for 100% inspection of leak test, inflation and deflation test.The defect related to functionality of the product will be culled out during inspection.Therefore, this complaint is not confirmed.
Event or Problem Description
A foley catheter was installed in the pavilion on (b)(6) 2022 in a patient undergoing cesarean section.On day 30, when trying to remove the catheter, the cuff could not be deflated, only 9 cc of serum came out (cuff inflated with 10 cc).Catheter can be removed.

• Brand Name: RUSCH GOLD 2W 5ML SIL STR H 14
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15491418
• Report Number: 8040412-2022-00275
• Device Sequence Number: 1905046
• Product Code: KOD
• UDI-Device Identifier: 14026704302205
• UDI-Public: 14026704302205
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: Health Professional
• Device Expiration Date: 08/28/2026
• Device Model Number: IPN050511
• Device Catalogue Number: 180705140
• Device Lot Number: KMA21J0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2021
• 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