MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH 2W 10ML 100% SILICONE STR H 20; CATHETER, RETENTION TYPE, BALL

Model Number	IPN050150
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "patient said she has a rash and the catheter keeps getting clogged due to a uti.Patient also said the tubing kinks and folds and causes back flow".Additional information received states that "the patient was having a lot of discharge causing the catheter to clog.The [doctor] changed them to this catheter and the catheter started kinking and separating from the collection bag.The caregiver stated that the rash was from the overflow of urine not draining into the bag.[the patient] is a quadriplegic".The patient status is reported as "fine".
Event or Problem Description
It was reported that "patient said she has a rash and the catheter keeps getting clogged due to a uti.Patient also said the tubing kinks and folds and causes back flow".Additional information received states that "the patient was having a lot of discharge causing the catheter to clog.The [doctor] changed them to this catheter and the catheter started kinking and separating from the collection bag.The caregiver stated that the rash was from the overflow of urine not draining into the bag.[the patient] is a quadriplegic".The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturing site reports: "as per recommended in ifu, the catheter shall be checked on weekly or periodic basis and the catheter shall be replaced at maximum of indwelling of 29 days and advice of the supervising physician.The materials used to produce the catheter were tested per en iso (b)(4), biological evaluation of medical devices.As reported in bev-0035/20, the catheter was reported to fulfill the requirements for their specified characteristics and performance, under the intended conditions and for its intended purpose of use.As per disclosed by the caregiver, the rashes were developed from the overflow of urine that was not drained into the collection bag.Therefore, this complaint is not confirmed as the rashes were not cause by the biocompatibility of the material or the functionality of the catheter used.".

• Brand Name: RUSCH 2W 10ML 100% SILICONE STR H 20
• Common Device Name: CATHETER, RETENTION TYPE, BALL
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16967224
• Report Number: 8040412-2023-00215
• Device Sequence Number: 14800611
• Product Code: EZL
• UDI-Device Identifier: 04026704308033
• UDI-Public: 04026704308033
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K972184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: Health Professional
• Device Model Number: IPN050150
• Device Catalogue Number: 170605200
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/23/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown