MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS

Model Number	IPN919492
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "incident occurred on (b)(6) 2025.Catheter fell out whereas the dressing was still in place, the thread was still in place under dressing.Catheter and tubing fell out, only the juncture hub remained.There was a temporary interruption of infusions." additional information received from the customer reports "i can't confirm what happened.According to the team, the female patient had already had this type of device inserted several times and was used to not touching it.It seems that she called the nurse directly after noticing the problem." there was no patient harm or injury.No medial intervention required.The patient's current condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).The reported device was not returned; however, the customer provided one photo for analysis.The photo shows a box clamp assembly sutured on the patient's skin.This box clamp assembly is meant to be assembled over the catheter body and acts as a secondary suture site.The juncture hub on the catheter is meant to be the primary suture site.According to the additional information provided by the customer, both the box clamp and juncture hub were sutured to the patient.Based on the photo, the customer report is confirmed; however, a full complaint investigation could not be performed without the sample returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "use a catheter stabilization device, catheter clamp and fastener, staples or sutures (where provided) use catheter hub as primary securement site.Use catheter clamp and fastener as a secondary securement site as necessary".Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "incident occurred on (b)(6) 2025.Catheter fell out whereas the dressing was still in place, the thread was still in place under dressing.Catheter and tubing fell out, only the juncture hub remained.There was a temporary interruption of infusions." additional information received from the customer reports "i can't confirm what happened.According to the team, the female patient had already had this type of device inserted several times and was used to not touching it.It seems that she called the nurse directly after noticing the problem." there was no patient harm or injury.No medial intervention required.The patient's current condition is reported as "stable".

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 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: 21807095
• Report Number: 3006425876-2025-00342
• Device Sequence Number: 18034458
• Product Code: DQY
• UDI-Device Identifier: 00801902105165
• UDI-Public: (01)00801902105165(11)240118(17)271231(10)71F24A0467(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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: IPN919492
• Device Catalogue Number: CV-04301
• Device Lot Number: 71F24A0467
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Female