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

Catalog Number CS-25703-E

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the middle of dilator is too narrow to use.

Manufacturer Narrative

Qn#(b)(4).The customer returned one dilator for analysis.No definite signs-of-use were observed.Visual analysis revealed that the dilator body contained an indention/groove towards the distal end.Microscopic examination confirmed the damage.No other defects or anomalies were observed.The deformed area of the dilator extrusion measured approximately 37mm-45mm from the distal tip.The dilator body from the hub to the tip measured 101mm, which is within the specification limits of 95.2mm-108mm per the dilator graphic.The dilator outer diameter at the proximal end measured 2.83mm, which is within the specification limits of 2.81mm-2.87mm per the dilator graphic.The dilator inner diameter measured 1.626mm, which is within the specification limits of 1.60mm-1.70mm per the dilator graphic.A lab inventory guide wire with the same diameter as the guide wire packaged with this finished kit was passed through the dilator.The guide wire could not pass completely through as it appeared to get stuck at the deformed area on the dilator.A device history record review was performed, and no relevant findings were identified.The report that a dilator was damaged/deformed was confirmed through complaint investigation.Visual analysis revealed that the dilator body contained an indention/groove towards the distal end.The dilator met all relevant dimensional requirements; however, the dilator did not meet the functional requirements due to the deformity.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the middle of dilator is too narrow to use.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9929370
• MDR Text Key: 186731301
• Report Number: 3006425876-2020-00302
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2021
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F19D1766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1