MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CV-15123-F

Device Problems Material Integrity Problem (2978); Material Too Soft/Flexible (4007)

Patient Problems Hematoma (1884); Tissue Damage (2104)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Complaint description: the catheter has a flexible dilator that impedes the effectiveness of the procedure.100% of the punctures performed with this catheter presented problems with mild and severe consequences for the patient, including injury to the vessel wall with local bleeding and the formation of severe hematoma".

Event Description

Complaint description: the catheter has a flexible dilator that impedes the effectiveness of the procedure.100% of the punctures performed with this catheter presented problems with mild and severe consequences for the patient, including injury to the vessel wall with local bleeding and the formation of severe hematoma.".

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: 3-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10437901
• MDR Text Key: 203892592
• Report Number: 3006425876-2020-00736
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K970864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/12/2023
• Device Catalogue Number: CV-15123-F
• Device Lot Number: 71F18M1082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other