MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35041-HPHNM
Medical Device Problem Codes	Component Misassembled (4004); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported " we opened a picc line today which was labelled as a dual lumen 5fr picc on the paperwork inside the plastic bag, but upon opening the bag, the sterile plastic tray contained a single lumen 4fr picc packed inside.Lot no.13f22m0077." no patient involvement was reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The customer photo shows a product lidstock with the part number indicated as pr-35552-hphnl on the lidstock pouch and as pr-35041-hphnm on the lidstock label.Based on this discrepancy the customer issue is confirmed.A device history record review was performed, and no relevant findings were identified.The customer report of an incorrect lidstock label was confirmed by visual inspection of the customer supplied photo.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 for reports of this nature.Corrected data: section h.6.-medical device problem code corrected to 4073.
Event or Problem Description
Customer reported " we opened a picc line today which was labelled as a dual lumen 5fr picc on the paperwork inside the plastic bag, but upon opening the bag, the sterile plastic tray contained a single lumen 4fr picc packed inside.Lot no.13f22m0077." no patient involvement was reported.

• Brand Name: ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG
• 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: 17664781
• Report Number: 9680794-2023-00617
• Device Sequence Number: 15234790
• Product Code: LJS
• UDI-Device Identifier: 00801902101051
• UDI-Public: 00801902101051
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• 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): 08/08/2023

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: 11/30/2024
• Device Catalogue Number: PR-35041-HPHNM
• Device Lot Number: 13F22M0077
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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