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

Catalog Number CS-25703-E

Device Problems Kinked (1339); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the dilator tends to kink and the tip of the dilator split during insertion.The device was replaced without issue.

Manufacturer Narrative

(b)(4).The customer returned an opened kit with a dilator.Visual examination revealed the tip of the dilator is frayed and folded.The dilator body contained a slight bend with white coloration, indicating stressing.The dilator contained one curve 17 mm from the distal end.The total length and outer diameter of the dilator were measured and were found to be within specification.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit instructs the user to perform a skin wheal prior to dilating skin.The customer complaint of a damaged dilator tip was confirmed by complaint investigation.The returned dilator tip was frayed and contained a slight curve.The damaged observed is consistent with excessive force.A device history record review was performed with no relevant findings.Based on the sample received, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that the dilator tends to kink and the tip of the dilator split during insertion.The device was replaced without issue.

• 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: 7371237
• MDR Text Key: 103534426
• Report Number: 3006425876-2018-00178
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2019
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F17J0189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1