MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC ARROWG+ARD; CATHETER

Model Number CDC-45703-P1A

Device Problem Positioning Failure (1158)

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

Event Date 01/31/2015

Event Type  malfunction  

Event Description

Critical patient in the emergency department required a stat central line placement.The physician followed the procedures as outlined for central line placement, but while attempting to place the catheter, the catheter would not pass over the guidewire.The guidewire was left in place and a new package containing another catheter was opened and this catheter passed and was placed fine with no complications.The catheter that failed was retained and is available for inspection.

• Brand Name: ARROWG+ARD
• Type of Device: CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC; 11245 n. distribution cove; olive branch MS 38654
• MDR Report Key: 4544154
• MDR Text Key: 15902032
• Report Number: 4544154
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2015

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: Physician
• Device Model Number: CDC-45703-P1A
• Device Lot Number: 23F14J0840
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR