MAUDE Adverse Event Report: ARROW INTL., INC. MULTI-LUMEN PI CVC KIT: 2-L 8 FR X 6"; ARROW+ARD CATHETER PRODUCTS

Catalog Number ASK-42802-PHPA2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2014

Event Type  malfunction  

Event Description

Info was received via medwatch report.It was reported that the pt came to the unit from the post-anesthesia care unit (pacu) with a double lumen internal jugular catheter with iv fluids infusing.The rn noticed a guide wire floating in the catheter.Pacu nurses said to switch the fluids to the other lumen.The anesthesiologist on the floor spoke with the pt and family about the wire.The tubing and wire where clamped.The doctor placed a peripherally inserted central line catheter and then removed the central line with the wire in place.A chest x-ray was completed and showed that the line was removed.There were no reported pt complications, injury or death as a result of this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: MULTI-LUMEN PI CVC KIT: 2-L 8 FR X 6"
• Type of Device: ARROW+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: john george, specialist ; 2400 bernville rd; reading, PA 19605
• MDR Report Key: 4366651
• MDR Text Key: 16173635
• Report Number: 1036844-2014-00534
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2014

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: 07/31/2015
• Device Catalogue Number: ASK-42802-PHPA2
• Device Lot Number: 23F14A1157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR