MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM/AT PI MIDLINE 2-L FG: 5.5FR X 15CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-41541-JHVA1

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer opened kit during procedure and what was labeled a double lumen midline was actually a single lumen midline.The midline was still placed without incident.The patient's condition was reported as fine.

Manufacturer Narrative

Qn# (b)(4).The actual sample was not returned; however, the customer provided one image showing a sticker label.The material#/lot# on the label is ask-41552-jhva1/13f22c0757.It was determined that this material number does not go with the lot number.Based on this discrepancy, the issue of an incorrect lidstock was confirmed through complaint investigation.Two device history record reviews were performed (one of the ask-41541-jhva1/13f22c0757 finished good, and one on ask-41552-jhva1/23f18m0457).A relevant finding was identified.A ship hold was initiated by morrisville due to the mismatch of product ask-41552-jhva1 and ask-41541-jhva1.The ifu provided with the kit informs the user, "read all package insert warnings , precautions and instructions prior to use.Failure to do so may result in severe patient injury or death".The report of incorrect lidstock was confirmed through analysis of the customer supplied photo.Visual analysis revealed that the lot number listed does not match with the material number listed.Based on the customer report and the photo provided, the root cause for this issue is design (labeling) related.A non-conformance was initiated to address the issue of a labeling mismatch.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer opened kit during procedure and what was labeled a double lumen midline was actually a single lumen midline.The midline was still placed without incident.The patient's condition was reported as fine.

• Brand Name: ARROW AM/AT PI MIDLINE 2-L FG: 5.5FR X 15CM
• Type of Device: 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: 14846333
• MDR Text Key: 295967338
• Report Number: 9680794-2022-00405
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: ASK-41541-JHVA1
• Device Lot Number: 13F22C0757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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: N/A.; N/A.