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	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
Patient reporting a 3rd failure of his rusch 100% 18fr 30cc foley.He said it is the same lot as the 2 you are already aware of.This one is key-mr.(b)(6).Told me the history and the 2 previous balloons burst after insertion and had not been pre-tested.The clinician that came to insert the latest catheter that failed pre-tested the balloon before insertion; it burst in his hand before 20ml water had been introduced.This eliminates the possibility of something within mr.(b)(6) bladder damaging the balloon (ie: stones, or diffusion due to osmosis, etc.).I just wanted to make you aware so that you could include the additional failure and new information on your report.
Event or Problem Description
Patient reporting a 3rd failure of his rusch 100% 18fr 30cc foley.He said it is the same lot as the 2 you are already aware of.This one is key-mr.W.Told me the history and the 2 previous balloons burst after insertion and had not been pre-tested.The clinician that came to insert the latest catheter that failed pre-tested the balloon before insertion; it burst in his hand before 20ml water had been introduced.This eliminates the possibility of something within mr.W.Bladder damaging the balloon (ie: stones, or diffusion due to osmosis, etc.).I just wanted to make you aware so that you could include the additional failure and new information on your report.
Additional Manufacturer Narrative
(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.No sample was returned for investigation; therefore, no physical investigation could be conducted.In the absence of any actual or representative sample for investigation, we could not further investigate to identify the actual root cause of this reported failure.Therefore, the complaint cannot be confirmed.

• 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: 14136307
• Report Number: 8040412-2022-00106
• Device Sequence Number: 20396732
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/18/2022
• 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