MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number IPN031155

Device Problem Crack (1135)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Customer reported that during placement of a subclavian cvc on an obese patient (due to thrombosis of various other veins the subclavian was the only access), the needle of the above-mentioned 4-lumen cvc broke between the plastic part and the needle after contact with the clavicle.The breakage occurred during the attempt to come underneath clavicle.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number 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

Customer reported that during placement of a subclavian cvc on an obese patient (due to thrombosis of various other veins the subclavian was the only access), the needle of the above-mentioned 4-lumen cvc broke between the plastic part and the needle after contact with the clavicle.The breakage occurred during the attempt to come underneath clavicle.

• Brand Name: CVC SET: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9458001
• MDR Text Key: 179433400
• Report Number: 3006425876-2019-01040
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN031155
• Device Catalogue Number: DE-15854-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.