MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "luer-lock connection (white & blue head) was block to be unable to exhaust." no patient harm reported.The device was replaced.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 3-lumen cvc for evaluation.Signs of use in the form of biological material were present in the medial extension line.Visual examination did not reveal any defects or anomalies.The extension lines did not contain any kinks or deformations.The instructions-for-use (ifu) provided with this kit instructs the user, "flush lumen(s) to completely clear blood from catheter." all three lumens were flushed using a water-filled lab inventory syringe.Resistance was encountered when flushing the medial and proximal lines.Some biological material came out the distal end of the catheter, but the lines were not able to be fully flushed.A lab inventory wire was inserted through both the medial and proximal lines and a significant amount of biological material was cleared from the lines.Again, the lines were flushed and this time all three functioned as expected.A lab inventory guide wire was able to pass through the returned catheter with minimal resistance after the biological material was cleared from the lines.A device history record review was performed with no relevant findings.The instructions-for-use (ifu) provided with this kit instructs the user, "flush lumen(s) to completely clear blood from catheter." the customer report of blocked lumens was confirmed by complaint investigation of the returned sample.Both the medial and proximal lumens contained a significant amount of biological material which caused a blockage.Once cleared, the catheter functioned as intended.A device history record review was performed with no relevant findings.Based on the condition of the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The complaint is reported as: "luer-lock connection (white & blue head) was block to be unable to exhaust." no patient harm reported.The device was replaced.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11505641
• MDR Text Key: 244783676
• Report Number: 3006425876-2021-00203
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/27/2022
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F20F2272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1