MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS

Catalog Number ES-04301

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

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

Event Date 03/16/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "on (b)(6) 2023, the patient's abdominal drainage tube was inserted with a 14cm internal tube and fixed with a patch.The puncture point exuded fluid on (b)(6) 2023 and at 19:00, the duty doctor made a pocket at the insertion site for use.At 20:30, the nurse found that the tube had a built-in 11cm mark during the ward inspection, and informed the duty doctor.Upon examination by the bedside, it was indicated that no treatment was needed.On the morning of march 17th, it was found that all the catheters had slipped out and were coiled in the stoma bag.The drainage tube was not fixed with sutures." the patient's condition was reported as fine.

Event Description

It was reported "on (b)(6) 2023, the patient's abdominal drainage tube was inserted with a 14cm internal tube and fixed with a patch.The puncture point exuded fluid on (b)(6) and at 19:00, the duty doctor made a pocket at the insertion site for use.At 20:30, the nurse found that the tube had a built-in 11cm mark during the ward inspection, and informed the duty doctor.Upon examination by the bedside, it was indicated that no treatment was needed.On the morning of (b)(6), it was found that all the catheters had slipped out and were coiled in the stoma bag.The drainage tube was not fixed with sutures." the patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and 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.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• 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: 17107795
• MDR Text Key: 316995835
• Report Number: 3006425876-2023-00562
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F22B0232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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: NOT REPORTED; NOT REPORTED