MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CV-15703

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: during the passage of the catheter, no blood return is obtained through the blue route, the permeability is removed and verified with saline solution, but it does not leak or return.

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.

Event Description

The customer reports: during the passage of the catheter, no blood return is obtained through the blue route, the permeability is removed and verified with saline solution, but it does not leak or return.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10029775
• MDR Text Key: 190054544
• Report Number: 3006425876-2020-00399
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CV-15703
• Device Lot Number: 14F19G0368
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.