MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 2672010

Device Problems Difficult to Flush (1251); Leak/Splash (1354); Aspiration Issue (2883)

Patient Problem Pain (1994)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

The port access was placed in the patient the day prior to the event.Event: registered nurse (rn) attempted twice to access the port.The patient complained there was pain and tenderness at the site of the port.The rn was unable to flush the port and get a blood return.Interventional radiology (ir) team was notified and the patient was transferred to interventional radiology to access the port.In ir, the port was accessed with no problem.Flushed and aspirated without resistance by the ir rn.The patient was sent for an mri, and the ir rn was called to mri after the technician said that the proximal hub kept leaking during test injection.The ir rn inspected the tubing and hub and could not visualize any defect.The ir rn replaced the clave and re-tested.Once again, the contrast shot out straight lateral from near the bottom of the clave.The huber needle was replaced and the same result was reproduced.Second needle and packaging for both access kits were retained for report/inspection by manufacturer.The ir supervisor notified cr bard to pick up the needles and packaging at this facility.

• Brand Name: PORT ACCESS KIT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7128010
• MDR Text Key: 95192562
• Report Number: 7128010
• Device Sequence Number: 1
• Product Code: LJT
• 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: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2672010
• Device Catalogue Number: 2672010
• Device Lot Number: REBV0435
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2017
• 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 Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 125