MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH 2W 20ML 100% SILICONE STR H 18; CATHETER, RETENTION TYPE, BALL

Model Number	IPN050171
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called stating that he had two catheter balloons to burst within the last week.One occurred after two days and the other occurred within hours of insertion.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Additional Manufacturer Narrative
(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.There was no complaint device returned for investigation.Therefore , no physical assessment could be conducted.In the absence of any actual or representative sample, further investigation could not be conducted to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.
Event or Problem Description
Customer called stating that he had two catheter balloons to burst within the last week.One occurred after two days and the other occurred within hours of insertion.

• Brand Name: RUSCH 2W 20ML 100% SILICONE STR H 18
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14115891
• Report Number: 8040412-2022-00098
• Device Sequence Number: 12245421
• Product Code: EZL
• UDI-Device Identifier: 04026704334964
• UDI-Public: 04026704334964
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: Lay User/Patient
• Device Expiration Date: 05/28/2026
• Device Model Number: IPN050171
• Device Catalogue Number: 170630180
• Device Lot Number: KME21F1171
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/31/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown