MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH PAED 2W 3ML 100% SILICONE STR H 08; CATHETER, RETENTION TYPE, BALL

Model Number	IPN050127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The catheter was installed in the patient for more than 24 hours, when it was unexpectedly cut from the junction of the lines with the catheter.
Additional Manufacturer Narrative
Qn# (b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.There is no sample return for investigation only photo provided.However, in the absence of actual sample for investigation, further investigation could not be conducted to determine the root cause to the failure condition.Therefore, this complaint could not be confirmed.
Event or Problem Description
The catheter was installed in the patient for more than 24 hours, when it was unexpectedly cut from the junction of the lines with the catheter.

• Brand Name: RUSCH PAED 2W 3ML 100% SILICONE STR H 08
• Common Device Name: CATHETER, RETENTION TYPE, BALL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11797078
• Report Number: 8040412-2021-00145
• Device Sequence Number: 4043574
• Product Code: EZL
• UDI-Device Identifier: 04026704307975
• UDI-Public: 04026704307975
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 02/28/2024
• Device Model Number: IPN050127
• Device Catalogue Number: 170003080
• Device Lot Number: 19CE09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1