MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 18 GA X 8" (20 CM); SYRINGE PISTON

Model Number	IPN919240
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "item without centimeter markings on catheters.Customer noticed this on all catheters from stock." associated complaints: 9680794-2024-00759, 9680794-2024-00760, 9680794-2024-00761, 9680794-2024-00762, 9680794-2024-00763 and 9680794-2024-00764.
Event or Problem Description
It was reported that: "item without centimeter markings on catheters.Customer noticed this on all catheters from stock." associated complaints: 9680794-2024-00759, 9680794-2024-00760, 9680794-2024-00761, 9680794-2024-00762, and 9680794-2024-00764.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided four photos for analysis and the images show the complaint details and kit components.The customer returned two unopened pediatric jugular sets for analysis.Due to the nature of the complaint, the returned kits were investigated as representative samples.The kits were opened to further analyze the catheters.No markings were observed on the returned catheter extrusions, which is the intended appearance of the catheter.Visual analysis of the reported catheter could not be performed as it was not returned for analysis.A review of the catheter product drawing was performed.The drawing does not include any markings on the catheter extrusion or hub.A review of change history was also performed, and no changes were made to the catheter with regards to markings on the extrusion or hub.A device history record review was performed with no relevant findings.The customer report of a missing catheter marking could not be confirmed in the returned representative samples.A review of the catheter product drawing revealed that neither the catheter extrusion nor the hub includes any markings.Therefore, no problem was found with the returned samples.However, an investigation of the reported catheter could not be performed as it was not returned for analysis.Therefore, the potential root cause could not be determined at this time.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: CVC SET: 18 GA X 8" (20 CM)
• Common Device Name: SYRINGE PISTON
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19958616
• Report Number: 9680794-2024-00763
• Device Sequence Number: 17926367
• Product Code: FMF
• UDI-Device Identifier: 00801902100542
• UDI-Public: (01)00801902100542(11)230906(17)280430(10)14F23J0008(21)
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K781978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: IPN919240
• Device Catalogue Number: ES-04218
• Device Lot Number: 14F23J0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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 Sex: Unknown