MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC: 2-L 5FR X 40CM W/ 80CM HYDRO NI; CATHETER, INTRAVASCULAR, THER

Catalog Number PR-34052-HPHNM

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported "lumen blockage." new set was used to complete the procedure.Patient condition unknown at time of report.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "lumen blockage." new set was used to complete the procedure.Patient condition unknown at time of report.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with several findings.For material mc-34052-200a and lots 13c21d0450, 13c21e1028 and 13c21g0235, non-conformances (ncs) were initiated for swg/catheter resistance.It cannot be determined if these ncs are associated with this complaint issue since the sample was not returned for investigation.For material c-15802-021d and lot 13c21b1456 , ncs were initiated for extension line leak during use.These ncs are not relevant to this complaint issue.For material c-15802-018a and lots 13c21b0434 and 13c20j1015, ncs were initiated in regards to extension line leak during use.These ncs are not relevant to this complaint issue.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW PI PICC: 2-L 5FR X 40CM W/ 80CM HYDRO NI
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16121276
• MDR Text Key: 306906069
• Report Number: 9680794-2023-00018
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: PR-34052-HPHNM
• Device Lot Number: 13F21J1120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED