MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number CV-12703

Device Problem Complete Blockage (1094)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: there was no flow back on one of the lines (catheter blocked).

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen cvc for evaluation.The sample contained obvious signs of use in the form of biological material.Visual examination did not reveal any defects or anomalies.The length of the returned catheter body measured to be 168 mm which is within specifications of 157-177 mm per product drawing.All three extension lines were initially flushed using a lab inventory syringe.Slight resistance was encountered while flushing the medial line.Once the biological material was cleared from the line, all lumens functioned as expected.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "indwelling catheters should be routinely inspected for desired flow rate, security of dressing, correct catheter position and for secure luer-lock connection.Use centimeter markings to identify if the catheter position has changed." the customer report of a blocked extension line could not be confirmed by complaint investigation of the returned sample.After the biological material was flushed from each line, all lumens functioned as expected.A device history record review was performed with no relevant findings.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: there was no flow back on one of the lines (catheter blocked).

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8561521
• MDR Text Key: 143552767
• Report Number: 3006425876-2019-00297
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F18B2413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1