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

Catalog Number EU-02031-ML

Device Problem Material Rupture (1546)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

It was reported that: injection of 80ml of iodine during a ct scan at 2.8ml/s into a mid-line arrow 20g device.The catheter body broke at the end of the injection, led it to be non-functional and impossible to use.We immediately removed the device to prevent bleeding.The nursing service was notified.No clinical consequences observed.Additional information: the sales rep informed staff that this device was not suitable for high pressure injections.Education is due to be carried out in the hospital department on high pressure injections and device compatibility.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).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 that: injection of 80ml of iodine during a ct scan at 2.8ml/s into a mid-line arrow 20g device.The catheter body broke at the end of the injection, led it to be non-functional and impossible to use.We immediately removed the device to prevent bleeding.The nursing service was notified.No clinical consequences observed.Additional information: the sales rep informed staff that this device was not suitable for high pressure injections.Education is due to be carried out in the hospital department on high pressure injections and device compatibility.

• Brand Name: ARROW MIDLINE CATHETERIZATION KIT
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 18854490
• MDR Text Key: 337509993
• Report Number: 3006425876-2024-00199
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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 Operator: Health Professional
• Device Catalogue Number: EU-02031-ML
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• 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: NOT REPORTED; NOT REPORTED