MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MIDLINE CATHETERIZATION KIT; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number IPN921110

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported "leaks were observed on the midline since insertion.The dressing is soaked with solution but no blood.We can inject but cannot withdraw blood.There is no valve on the midline." the midline was removed and replaced.Midline was used on an animal.The condition of the animal is "unknown" at this time.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(6) additional information received (b)(6)2024 indicates there were no clinical consequences and no impact on patient condition.Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.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.

Event Description

It was reported "leaks were observed on the midline since insertion.The dressing is soaked with solution but no blood.We can inject but cannot withdraw blood.There is no valve on the midline." the midline was removed and replaced.Midline was used on an animal.The condition of the animal is "unknown" at this time.

• Brand Name: ARROW MIDLINE CATHETERIZATION KIT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18626970
• MDR Text Key: 334354001
• Report Number: 3006425876-2024-00085
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN921110
• Device Catalogue Number: EU-02041-ML
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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