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

Catalog Number CV-17702-E

Device Problems Difficult to Insert (1316); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The customer reports the dilator failed to be inserted and was found damaged during use.

Event Description

The customer reports the dilator failed to be inserted and was found damaged during use.

Manufacturer Narrative

(b)(4).The customer returned a single dilator for evaluation.Microscopic examination revealed the sample contained signs of use in the form of biological material inside the tip.The returned dilator tip was torn back on the side and the dilator is split around the circumference.The torn side and fold all contained white coloration , indicating stress.The dilator body length and outer diameter were measured and were found to be within specification.A device history record review was performed on the dilator and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit describes instructions for dilator insertion.It states to "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide" prior to dilator insertion.The ifu also cautions the user "alcohol and acetone can weaken the structure of polyurethane material.Therefore, care should be taken when instilling drugs containing alcohol or when using high concentration of alcohol or acetone when performing routine catheter care and maintenance." the reported complaint of the dilator tip damaged during use was confirmed by complaint investigation.The returned dilator was cracked and the material was folded back.The dilator tip contained discoloration at the cracks, indicating stress.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample received, it was determined that 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: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8217819
• MDR Text Key: 132108515
• Report Number: 3006425876-2019-00017
• 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: 12/14/2019

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: No Information
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F16H0855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Manufacturer Received: 12/14/2019
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1