MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number CS-15853-E

Device Problem Migration (4003)

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

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Potential lot numbers: 71f18j0107; 71f18g2108; 71f18g0036.It is unknown if the device is available for evaluation.

Event Description

It was reported that a catheter was inserted on friday (b)(6) 2019.The catheter had to be removed within the week end because of the pain encountered during infusions.When the nurse removed the catheter, she noticed that only 2 cm of the catheter were removed from the patient, thus the rest was still in the patient.Nevertheless, an x-ray was performed, and nothing was found.Additional information received indicates that the device did not break or rupture.It is reported that the doctor suggests that the small wings of the luer would have induced a rise of the distal part of the catheter and thus some pain for the patient.

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

It was reported that a catheter was inserted on friday (b)(6) 2019.The catheter had to be removed within the week end because of the pain encountered during infusions.When the nurse removed the catheter, she noticed that only 2 cm of the catheter were removed from the patient, thus the rest was still in the patient.Nevertheless, an x-ray was performed, and nothing was found.Additional information received indicates that the device did not break or rupture.It is reported that the doctor suggests that the small wings of the luer would have induced a rise of the distal part of the catheter and thus some pain for the patient.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8296753
• MDR Text Key: 134732899
• Report Number: 3006425876-2019-00061
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15853-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1