MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT; CENTRAL VENOUS CATHETER, SHORT-TERM LESS THAN 30 DAYS

Catalog Number CDC-42703-XP1A

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  malfunction  

Event Description

Arrow multi-lumen central venous catheterization kit.After placement of central line, physician noted difficulty removing guidewire.Physician was able to remove guidewire which looks thinned and stripped.This is the second similar event at this facility with this device within one week.Manufacturer notified and device returned.Manufacturer response for central line kit, arrow multi-lumen central venous catheterization kit (per site reporter).Teleflex customer service contacted.Product picked up teleflex medical sales representative.

Event Description

Sc-1132 (sn: 134615) device evaluation indicated that the ipg passed all tests performed.

• Brand Name: ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT
• Type of Device: CENTRAL VENOUS CATHETER, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 8573110
• MDR Text Key: 143834092
• Report Number: 8573110
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2019,04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDC-42703-XP1A
• Device Lot Number: 23F19B0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Weight: 155