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

Model Number IPN030885

Device Problems Complete Blockage (1094); Difficult to Flush (1251)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown when the alleged issue was detected.

Event Description

It was reported that two from three lumens cannot be flushed or rinsed through.

Manufacturer Narrative

(b)(4).The customer returned one opened kit containing a 3-lumen cvc for evaluation.The catheter contained obvious signs of use in the form of biological material.Visual examination did not reveal any defects or anomalies.The total length of the returned catheter measured to be 217 mm which is within specifications of 207-227 mm per product drawing.All three lumens were flushed using a water-filled lab inventory syringe.When the medial and proximal lines were flushed, significant resistance was encountered.Biological material was removed from the lines and all three lumens were able to flush as intended.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user to prepare the catheter, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s).".The customer report of two blocked lumens was confirmed by functional testing of the returned sample.However, once biological material was removed from the lines, all three lumens 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 caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that two from three lumens cannot be flushed or rinsed through.

• 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: 10345108
• MDR Text Key: 201612146
• Report Number: 3006425876-2020-00661
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN030885
• Device Catalogue Number: CV-15703
• Device Lot Number: 71F19H0305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1