MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45541-CURVB
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the package was open at the top left corner upon removing from the case.The kit was no longer sterile.No patient involvement.
Event or Problem Description
It was reported the package was open at the top left corner upon removing from the case.The kit was no longer sterile.No patient i nvolvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one, picc kit for analysis.Visual analysis revealed that the top-left corner of the lidstock was opened.Further analysis revealed that the adhesive imprint was still present on the tray and was uniform.This indicates that the seal was correctly applied to the kit (incorrect sealing can typically be observed by uneven or inconsistent adhesive imprint).Packaging was contacted as part of this complaint investigation.Based on the returned sample, they confirmed that the tray was correctly sealed during packaging.After these kits undergo sealing with the multivac, they are moved to the packaging without any further manipulation.The seals are also 100% inspected to ensure they are intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit, informs the user, "do not use if package is damaged".The report that a kit was partially opened was able to be confirmed through complaint investigation.Visual analysis revealed that the lidstock was peeled back at the top-left corner of the tray; however, the appearance of the residue adhesive on the tray suggests that the kit was sealed correctly.Further confirmation from packaging revealed that these seals are 100% inspected for such damage.Based on the customer report and the sample received, the root cause cannot be determined as it is unknown when the sterile barrier became breached.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 17794901
• Report Number: 9680794-2023-00683
• Device Sequence Number: 13990567
• Product Code: LJS
• UDI-Device Identifier: 10801902208696
• UDI-Public: 10801902208696
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• 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): 08/28/2023

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: 03/31/2024
• Device Catalogue Number: DLX-45541-CURVB
• Device Lot Number: 13F22L0946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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