MAUDE Adverse Event Report: COVIDIEN LLC CONNECTOR 45103 CSF-CATH STRAIGHT IMP; TURBIDIMETRIC METHOD, TRIGLYCERIDES

Model Number	45103
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a catheter.It was reported that the drainage tube of left ventricle of the brain was placed in the operating room, and the drainage was smooth after operation.10-22 22:30 the junction of the drainage tube outside the ventricle of the patient fell off.Removed the short end of the short tube and connected the two ends directly.The cause of the event was reported to likely be due material issue of the device.The reported impact to patient was an increased risk of infection.(b)(6) 2022.Rep: no new information.
Additional Manufacturer Narrative
No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONNECTOR 45103 CSF-CATH STRAIGHT IMP
• Common Device Name: TURBIDIMETRIC METHOD, TRIGLYCERIDES
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15869224
• Report Number: 9612501-2022-02069
• Device Sequence Number: 5219195
• Product Code: JGX
• UDI-Device Identifier: 00763000027759
• UDI-Public: 00763000027759
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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 Model Number: 45103
• Device Catalogue Number: 45103
• Device Lot Number: 0223993082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2022
• 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 Age: 30 YR
• Patient Sex: Female