MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN918647
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2026 a female patient was sent to the pet ct scan department.I received a phone call from the pet ct team informing me that, during the transfer of the patient, the distal lumen cap came off.The nurse reported that the incident happened right in front of her; the clamp was properly closed at the time, and she reacted immediately by applying antiseptic compresses in an occlusive manner to the end.When the patient arrived, i observed that the distal lumen of the triple lumen central venous catheter (inserted in icu on (b)(6) 2026) was broken between the clamp and the brown hub.The clamp was still securely clamped, and the compresses and protective dressing were still in place.The doctor was informed and decided to remove the central venous catheter." there were no patient complications.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The image shows the distal brown luer hub with no extension line connected.Attached to the proximal end of the luer hub is an additional clear line with two stopcocks.The complaint of extension line/luer hub separation was able to be confirmed by the photo; however, a complete visual inspection to evaluate the cause of the damage 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
It was reported that " on (b)(6) 2026 a female patient was sent to the pet ct scan department.I received a phone call from the pet ct team informing me that, during the transfer of the patient, the distal lumen cap came off.The nurse reported that the incident happened right in front of her; the clamp was properly closed at the time, and she reacted immediately by applying antiseptic compresses in an occlusive manner to the end.When the patient arrived, i observed that the distal lumen of the triple lumen central venous catheter (inserted in icu on (b)(6) 2026) was broken between the clamp and the brown hub.The clamp was still securely clamped, and the compresses and protective dressing were still in place.The doctor was informed and decided to remove the central venous catheter." there were no patient complications.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• 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: 24558551
• Report Number: 3006425876-2026-00277
• Device Sequence Number: 13121688
• Product Code: DQY
• UDI-Device Identifier: 10801902029017
• UDI-Public: (01)10801902029017(11)250924(17)291130(10)71F25J0819(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: IPN918647
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F25J0819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2025
• 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: Unknown