MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 30CM; CATHETER, PERCUTANEOUS

Model Number IPN031621

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported that when a cvc is placed, the dilator is spread out.The needle was easy to insert, the skin was age-appropriate, and the anesthetist was very experienced.

Event Description

Customer reported that when a cvc is placed, the dilator is spread out.The needle was easy to insert, the skin was age-appropriate , and the anesthetist was very experienced.

Manufacturer Narrative

Qn#(b)(4).The customer returned one product lidstock and dilator for evaluation.Visual examination confirmed the dilator tip was severely split and damaged.The split contained white coloration, which is damage consistent with undue force being applied to the tip.The total length of the returned dilator measured to be 4.02" which is within specifications of 3.75-4.25" per product drawing.The outer diameter of the returned dilator measured to be 0.136" which is within specifications of 0.135-0.138" per product drawing.The inner diameter of the dilator tip could not be measured due to the damage observed.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user to enlarge the site with a scalpel prior to dilating skin.The customer report of a damaged dilator tip was confirmed by complaint investigation of the returned sample and photos.The dilator tip was severely split and torn, which is damage consistent with undue force being applied to the tip.The sample passed all relevant dimensional testing and 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.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 30CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10494687
• MDR Text Key: 205690665
• Report Number: 3006425876-2020-00784
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN031621
• Device Catalogue Number: EU-14854-EN
• Device Lot Number: 71F20D0680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1