MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 8 CM; CATHETER PERCUTANEOUS

Model Number	IPN918853
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during cvc insertion in right femoral on 1 year old baby, it was observed that the swg kinked 90 degrees when the introducing the dilator.The swg was already in place and confirmed via echography.This happened twice with this patient on the same day with the same lot number.It was not possible to reinsert new cvc in the same insertion site as hematoma appeared.A new cvc was inserted in the left femoral.As a result, it prolonged the sedation time with hemorrhagic and infection risk for the baby".
Event or Problem Description
It was reported that "during cvc insertion in right femoral on 1 year old baby, it was observed that the swg kinked 90 degrees when the introducing the dilator.The swg was already in place and confirmed via echography.This happened twice with this patient on the same day with the same lot number.It was not possible to reinsert new cvc in the same insertion site as hematoma appeared.A new cvc was inserted in the left femoral.As a result, it prolonged the sedation time with hemorrhagic and infection risk for the baby".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 8 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20964994
• Report Number: 3006425876-2024-01235
• Device Sequence Number: 3955024
• Product Code: DQY
• UDI-Device Identifier: 30801929122979
• UDI-Public: (01)30801929122979(11)230926(17)280731(10)71F23H0899(21)
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: IPN918853
• Device Catalogue Number: CS-15553-E
• Device Lot Number: 71F23H0899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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: 12 MO
• Patient Sex: Unknown