MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN; CATHETER INTRAVASCULAR THERAPE

Catalog Number	ASK-45703-PGM3
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the kit is suppose to contain a 20cm catheter.The catheter packaged in it was a 16cm catheter." the issue was detected prior to use.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one catheter and product lidstock for analysis.The returned catheter was a 3l 7fr x 16cm catheter.Analysis of the product lidstock revealed that the catheter intended to be within the kit is a 3l 7fr x 20cm catheter.Therefore, the returned catheter is not consistent with the intended kit contents.The overall length of the catheter measured 167mm which is not within the specification limits of 207-227mm per the catheter product drawing.This confirms the customer report of an incorrect catheter being placed within the kit.A review of the bill of materials was performed.It was confirmed that the intended catheter within the ask-45703-pgm3 kit is a 20cm catheter, which is not consistent with the returned 16cm catheter.A device history record review was performed and a relevant finding was identified.A non-conformance was initiated for material ask-45703-pgm3 with batch 33f23l0683 regarding a component incorrect , catheter.The customer report of an incorrect catheter was confirmed through the returned sample.The customer returned one 7fr x 16cm catheter.Analysis of the bill of materials and product lidstock revealed that the catheter intended to be within the kit is a 7fr x 20cm catheter, which is not consistent with the returned catheter.Therefore, packaging likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: "the kit is suppose to contain a 20cm catheter.The catheter packaged in it was a 16cm catheter." the issue was detected prior to use.

• Brand Name: ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20038267
• Report Number: 9680794-2024-00799
• Device Sequence Number: 6508511
• Product Code: FOZ
• UDI-Device Identifier: 10801902213768
• UDI-Public: (01)10801902213768(11)240105(17)250430(10)33F23L0683(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: ASK-45703-PGM3
• Device Lot Number: 33F23L0683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown