MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CS-27702-E

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint description: the dilator body/hub damaged during use.

Manufacturer Narrative

(b)(4).The customer returned an opened kit containing many components for.The dilator will be evaluated in this investigation.Visual and microscopic examination of the dilator tip revealed the distal tip was slightly misshapen into an oval, and the tip material appears to be pushed outwards indicating a force applied to the tip.The dilator tip inner diameter measured 0.965 mm which is within the specification of 0.91-0.97 mm per dilator product drawing.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit instructs the user to perform a skin wheal prior to dilating the skin.The complaint report of a damaged dilator tip was confirmed through evaluation of the returned sample.The tip of the returned dilator was slightly misshapen into an oval shape indicating stress.The sample met all relevant dimensional requirements and a device history record review did not reveal any manufacturing issues.Based on the condition of the returned sample and the evidence of use, it was determined that the probable root cause is unintentional use error.Teleflex will continue to monitor and trend reports of this nature.

Event Description

Complaint description: the dilator body/hub damaged during use.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8180341
• MDR Text Key: 130895415
• Report Number: 3006425876-2018-00805
• 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: 12/11/2018

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: 04/28/2020
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F18E0251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1