MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 2L INTRAVENOUS SET; CATHETER, INTRAVASCULAR, THER

Catalog Number	IV-01100
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during operation preparation and flushing doctor found out that is impossible to flush catheter and that inside of tube is a piece of wire." this defect was found during preperation therfore no patient harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during operation preparation and flushing doctor found out that is impossible to flush catheter and that inside of tube is a piece of wire." this defect was found during preparation therefore no patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The photos show the extension line with what appears to be a strip of metal inside.The customer also returned an opened iv-01100 kit with the twin-cath two-lumen catheter for evaluation.Visual inspection revealed that there were no signs of use observed.There appeared to be a thin strip of metal material within the proximal extension line.After severing the extension line , the strip of metal was observed to be flat.No other defects or anomalies were observed on the returned sample.The proximal extension line was severed to remove the metal strip for dimensional analysis.The length of the metal strip within the extension line measured 24 mm.The outer diameter of the metal strip measured 0.373 mm.Manufacturing was contacted as a part of this complaint investigation.The confirmed that the metal strip within the extension line is part of a core pin used during the molding process of the juncture hub.A device history record review was performed, and no relevant findings were identified.The customer report of a foreign material within the extension line was confirmed by investigation of the returned sample.Visual analysis revealed a strip of metal was within the extension line.Manufacturing confirmed that the observed defect occurred during the juncture hub molding process.Based on these circumstances, manufacturing-molding likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW 2L INTRAVENOUS SET
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18977539
• Report Number: 9680794-2024-00284
• Device Sequence Number: 12381852
• Product Code: FOZ
• UDI-Device Identifier: 00801902001016
• UDI-Public: 00801902001016
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K862153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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 Catalogue Number: IV-01100
• Device Lot Number: 14F23H0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown