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

Catalog Number CS-25854-E

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); Discomfort (2330)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that there was a tear in the medial lumen and a fluid leak was observed.

Event Description

The customer reports that there was a tear in the medial lumen and a fluid leak was observed.

Manufacturer Narrative

(b)(4).The customer returned one 4-lumen catheter.After the sample failed functional testing, the medial 2 line was microscopically examined.A small slit was detected in the extension line, which is damage consistently seen when the component comes in contact with a sharp object (needle, scissors, scalpel, etc.).The edges were smooth and straight.The medial 2 extension line contained one small cut 71 mm from the luer hub.The total length of the catheter body measured to be 216 mm which is within specifications of 207-227 mm per product drawing.The inner and outer diameter of the medial 2 extension line were also within specification.The returned catheter was initially flushed using a lab inventory syringe to ensure no blockages were present.The distal tip was then occluded and all four lumens were pressurized using a lab inventory syringe.A small leak was detected in the medial 2 extension line.No other lumens contained any leaks.A device history record review was performed based on sales history with no relevant findings.The ifu provided with this kit warns the user, "do not cut catheter to alter length." the customer report of an extension line leak was confirmed by complaint investigation of the returned sample.The medial 2 extension line contained one small slit, consistent with coming in contact with a sharp object.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 (contact with sharps) likely 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 8.5 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8807583
• MDR Text Key: 151597754
• Report Number: 3006425876-2019-00503
• 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: 07/01/2019

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 Catalogue Number: CS-25854-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1