MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH 2W 30ML 100% SILICONE STR H 24; CATHETER, RETENTION TYPE, BALL

Model Number IPN050177

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

Customer states that over a short period of time the cuff leaks thus allowing the catheter to fall out.This happened over a period of time with three different catheters.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

• Brand Name: RUSCH 2W 30ML 100% SILICONE STR H 24
• Type of Device: 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15537894
• MDR Text Key: 305620967
• Report Number: 8040412-2022-00284
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 04026704334995
• UDI-Public: 04026704334995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: IPN050177
• Device Catalogue Number: 170630240
• Device Lot Number: KME21E1489
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1