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
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
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 this is the third incident with this batch on the same client.
Additional Manufacturer Narrative
Qn#(b)(4).An actual sample was returned for investigation.Visual examination on the catheter showed that the shaft already cut at approximately 150mm from tip.There was also tape residue at the lower shaft.Other than that, no sign of kinking, clamp mark or collapse lumen observed throughout the shaft.The funnel of the catheter was inserted with water and observed the water flow out from the cut area which indicated no blockage or collapsed lumen in the inflation airline.The balloon area was cut to see the inflation eye condition.Based on observation, no foreign matter or blockage at the inflation eye area.Then, syringe attached with needle was used to insert the water through the cut area and observed the water flow out from the inflation eye which indicated no blockage or collapsed lumen at the inflation airline.In summary.Based on the investigation, there was no collapsed lumen or blockage observed through the inflation airline.The inflation eye also normal and no foreign matter which can block the deflation process.Since the catheter was already cut during received, no inflation and deflation process able to be conducted.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 this is the third incident with this batch on the same client.

• 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: 15491496
• Report Number: 8040412-2022-00274
• Device Sequence Number: 1856742
• 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: KMA21J0020
• 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: 10/28/2022
• 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