MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN923910
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " an incident occurred on (b)(6) 2025 in our hospital's post anesthesia care unit.While inserting a catheter in the emergency room in response to haemorrhagic shock, a problem was encountered with the puncture needle.It appeared to be multi-perforated, making it impossible to draw blood.A second operator took over and changed the syringe, but with the same result.A third operator took over and changed the needle, which proved successful: they were able to draw blood and insert the catheter."there was a delay for the massive transfusion.The patient's current condition is reported as "deceased".Additional information was requested from the customer; however, further details have not been provided at this time.
Additional Manufacturer Narrative
(b)(4).Additional information received from the customer indicates "the patient had an accident and arrived in serious condition.Even if the problem with the mac may have delayed her treatment slightly, it was not the cause of death." the customer returned an unopened, representative si-11142 kit for analysis.The kit was opened to analyze the contents within.Visual analysis did not reveal any defects or anomalies with the introducer needle.The needle was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user , "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe [ars] (where provided) into vein and aspirate." the returned needle was attached to the ars and was able to aspirate water as intended.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol , acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents may also weaken the adhesive bond between catheter stabilization device and skin." the customer report of needle hub cracked was not confirmed by complaint investigation of the returned sample.An unused representative sample was returned, however, the device from the reported event was not returned.A device history record review was performed, and no relevant findings were identified.No damage or anomalies were observed with the introducer needle from the returned representative sample.Without the reported 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.
Event or Problem Description
It was reported that " an incident occurred on (b)(6) 2025 in our hospital's post anesthesia care unit.While inserting a catheter in the emergency room in response to haemorrhagic shock, a problem was encountered with the puncture needle.It appeared to be multi-perforated, making it impossible to draw blood.A second operator took over and changed the syringe, but with the same result.A third operator took over and changed the needle, which proved successful: they were able to draw blood and insert the catheter."there was a delay for the massive transfusion.The patient's current condition is reported as "deceased".Associated mdr numbers include: 3006425876-2025-00903 and 3006425876-2025-00904.

• Brand Name: ARROW MULTILUMEN/PSI SET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 23199789
• Report Number: 3006425876-2025-00903
• Device Sequence Number: 13046215
• Product Code: FOZ
• UDI-Device Identifier: 00801902102898
• UDI-Public: (01)00801902102898(11)240422(17)280928(10)71F24D0734(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K002507
• 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): 09/09/2025

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: IPN923910
• Device Catalogue Number: SI-11142
• Device Lot Number: 71F24D0734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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: Unknown