MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number SA-25854-EU

Device Problem Defective Component (2292)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/04/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device (catalog#) is not intended for sale in the us.Similar device/component sold in the us.

Event Description

It was reported that the physician struggled apparently on insertion of mentioned cvc set, with vessel dilator.A 2nd set same opened, the same problem with vessel dilator experienced.The first event documented in mdr #3006425876-2018-00754.The customer reports the tip appears damaged.A 3rd cvc set the same opened-successful placement.

Event Description

It was reported that the physician struggled apparently on insertion of mentioned cvc set, with vessel dilator.A 2nd set same opened, the same problem with vessel dilator experienced.The first event documented in mdr #3006425876-2018-00754.The customer reports the tip appears damaged.A 3rd cvc set the same opened-successful placement.

Manufacturer Narrative

(b)(4).The customer returned a single dilator and the product lidstock for evaluation.Visual and microscopic examination of the dilator tip did not reveal any defects or anomalies.The dilator distal tip was round, fully formed and undamaged.The dilator tip inner diameter and the dilator body outer diameter were measured and 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) supplied with this kit instructs the user to "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide" prior to dilator insertion.The instructions-for-use (ifu) supplied with this kit instruct the user to "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide" prior to dilator insertion.The customer report of a damaged dilator tip could not be confirmed through evaluation of the returned sample.The tip of the returned dilator was round, full and appeared as expected.The sample met all relevant dimensional requirements and a device history record review did not reveal any manufacturing issues.Based on the investigation, no problem was found on the returned sample.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8115778
• MDR Text Key: 128774739
• Report Number: 3006425876-2018-00753
• 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: 11/14/2018

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: 04/29/2020
• Device Catalogue Number: SA-25854-EU
• Device Lot Number: 71F18E1253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1