MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; INTRODUCER, CATHETER

Model Number IPN033893

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/25/2018

Event Type  malfunction  

Event Description

Patient admitted to icu with 2/2 iv fluids running through cordis.Cordis placed in right femoral vein.Rn was attempting to draw lab work from cordis and only aspirated air.Question of cordis with hole or other equipment malfunction.Notified doctor and cordis was replaced over a guide wire.Notified supervisor.

• Brand Name: ARROW
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 7348431
• MDR Text Key: 102738632
• Report Number: 7348431
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801902005519
• UDI-Public: (01)00801902005519
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: IPN033893
• Device Catalogue Number: AK-09903-S
• Device Lot Number: 23R16D0616
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 110