MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number IPN918521

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2023

Event Type  malfunction  

Event Description

It was reported the patient experienced hypoglycemia and confusion during the night.The cvc was initally found securely attached with the dressing and statlock however, one lumen was disconnected.Subsequently, in the morning one lumen of the cvc was found on the floor.Antibiotic treatment was administered and the cvc was removed and replaced with a picc line instead.The current patient's current condition reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The report of a separated extension line was confirmed through complaint investigation of the returned sample.The customer returned one, 2-lumen cvc for analysis.Signs-of-use in the form of biological material were observed inside the catheter body.It was noted that the severed extension line was not returned for analysis.Visual analysis revealed that the proximal extension line had separated from the juncture hub.A small portion of the extension line was still molded within the juncture hub.Microscopic examination confirmed the damage and revealed that the edges of the separation were slightly rough/jagged.It was also noted that the point of separation was within the inside lip of the juncture hub.Visual analysis could not be performed on the severed extension line to determine the nature of the break as it was not returned for analysis.The extension line inner diameter measured 1.4478mm via calibrated pin gauge, which was within the specification limits of 1.420mm-1.500mm per the proximal extension line extrusion product drawing.The proximal extension line outer diameter could not be accurately measured as it was located within the lip of the juncture hub.Likewise, the inner/outer diameter of the severed portion of the extension line could not be measured as it was not returned.Functional analysis could not be accurately performed due to the severity of the damage on the returned sample.The instructions for use (ifu) provided with this kit warns the user, "using catheters not indicated for pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." a device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause could not be determined without the severed line also returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported the patient experienced hypoglycemia and confusion during the night.The cvc was initally found securely attached with the dressing and statlock however, one lumen was disconnected.Subsequently, in the morning one lumen of the cvc was found on the floor.Antibiotic treatment was administered and the cvc was removed and replaced with a picc line instead.The current patient's current condition reported as "fine.".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 16 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18658349
• MDR Text Key: 334737909
• Report Number: 3006425876-2024-00098
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN918521
• Device Catalogue Number: CV-12702
• Device Lot Number: 71F23B1137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2023
• 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