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

Catalog Number CV-15703

Device Problems Complete Blockage (1094); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It is reported that after insertion of the catheter, the doctor noticed that it was impossible to collect blood from the patient using the catheter.The catheter was removed, and the staff observed that the catheter was "welded" on the distal side.

Event Description

It is reported that after insertion of the catheter, the doctor noticed that it was impossible to collect blood from the patient using the catheter.The catheter was removed , and the staff observed that the catheter was "welded" on the distal side.

Manufacturer Narrative

(b)(4).The customer returned one, cvc catheter and a lidstock for analysis.Signs-of-use in the form of biological material was observed on the outside of the catheter body.Visual analysis of the returned sample revealed that the catheter tip was flattened/crushed.This caused the distal lumen to be completely occluded.Microscopic examination revealed what appears to be adhesive residue on one side of the defective catheter tip.Analysis of the underside of the lidstock revealed a small mark on the inner circumference of the seal.This mark appeared to be an indentation from the catheter tip.This indicates that the catheter tip was likely caught in the seal between the tray and the lidstock during the packaging process.A lab inventory guide wire could not be advanced through the distal lumen as the catheter tip was occluded.A long pin gage was passed through the medial and proximal lumens.The pin gage was able to pass completely through the lumens with little to no resistance.A device history record review was not required as part of this complaint investigation.The reported complaint of a blocked catheter was confirmed through complaint investigation.Visual analysis revealed that the returned catheter was severely compressed at the tip.Microscopic examination revealed adhesive residue on one side of the defective catheter tip.This indicates that the catheter likely was caught between the lidstock and the tray during the sealing process.Based on the customer description and the observed damage, it is not known how the customer managed to insert the catheter; however, the observed damage was likely due to a packaging defect.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 9309565
• MDR Text Key: 178643780
• Report Number: 3006425876-2019-00895
• 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: 10/29/2019

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: CV-15703
• Device Lot Number: 71F19H1015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1