MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 2-L 8 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-42802-XP1A
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A quantity of 10 devices was reported.Associated mdrs: 9680794-2023-00672, 9680794-2023-00664, 9680794-2023-00665, 9680794-2023-00666, 9680794-2023-00667, 9680794-2023-00668, 9680794-2023-00669, 9680794-2023-00670, 9680794-2023-00671.
Event or Problem Description
The complaint is reported as: package lidstock and side card do not match regarding the sku and product description.The lidstock is showing cdc-45703-xp1a and the side card is showing cdc-42808-xp1a.The tray should be a double lumen tray for cdc-42802-xp1a.They discovered the trays were mislabeled as they were in surgery but still needed to use them due to not having other trays to trade out with at the time.
Additional Manufacturer Narrative
Qn#(b)(4).The report of an incorrect pouch label was confirmed by complaint analysis of the customer supplied photos.It was noted that the pouch label was for a cdc-45703-xp1a kit; however, the lidstock/sticker label was for a cdc-42802-xp1a kit.The device history record review consisted of an analysis of the manufacturing facility quality systems documents and no relevant findings were identified.Based on the customer report and the supplied photos, packaging caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.A quantity of 10 devices was reported.Associated mdrs: 9680794-2023-00672, 9680794-2023-00664, 9680794-2023-00665, 9680794-2023-00666, 9680794-2023-00667, 9680794-2023-00668, 9680794-2023-00669, 9680794-2023-00670, 9680794-2023-00671.
Event or Problem Description
The complaint is reported as: package lidstock and side card do not match regarding the sku and product description.The lidstock is showing cdc-45703-xp1a and the side card is showing cdc-42808-xp1a.The tray should be a double lumen tray for cdc-42802-xp1a.They discovered the trays were mislabeled as they were in surgery but still needed to use them due to not having other trays to trade out with at the time.

• Brand Name: ARROW PI CVC KIT: 2-L 8 FR X 16 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17728735
• Report Number: 9680794-2023-00656
• Device Sequence Number: 15088763
• Product Code: FOZ
• UDI-Device Identifier: 10801902117110
• UDI-Public: 10801902117110
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: CDC-42802-XP1A
• Device Lot Number: 36F22K0020
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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