MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER PERCUTANEOUS

Model Number	IPN038307
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as: the catheter was inserted with ultrasound guidance in right subclavian.After puncture in the vein, it was impossible to advance the guide in the metallic tunnel (needle) of the syringe.A hematoma appeared.After removal of the device, a defect of the needle was observed.The needle separated from the hub.Another puncture was performed with another device.The patient's condition is reported to be fine.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
The complaint is reported as: the catheter was inserted with ultrasound guidance in right subclavian.After puncture in the vein, it was impossible to advance the guide in the metallic tunnel (needle) of the syringe.A hematoma appeared.After removal of the device, a defect of the needle was observed.The needle separated from the hub.Another puncture was performed with another device.The patient's condition is reported to be fine.
Additional Manufacturer Narrative
(b)(4).New information received indicates that this was not a reportable event, thus, the initial mdr submitted on (b)(6) 2021, and the follow-up mdr submitted on (b)(6) 2021 should both be retracted.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12492036
• Report Number: 3006425876-2021-00878
• Device Sequence Number: 5087687
• Product Code: DQY
• UDI-Device Identifier: 10801902139075
• UDI-Public: 10801902139075
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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: No Information
• Device Expiration Date: 03/31/2025
• Device Model Number: IPN038307
• Device Catalogue Number: CS-14703
• Device Lot Number: 71F20F2388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/28/2021; 10/28/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/28/2021; 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1