MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0031YN

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 07/19/2018

Event Type  malfunction  

Event Description

Pt was accessed with a 20g 3/4 inch safestep huber needle primed with normal saline.No issues identified at that time.Premedications and fluids ran without issue.Blood return was checked via the side port on huber prior to administering chemotherapy.The 5-7 minutes late, patient complained of "leaking" of iv tubing.Chemo infusion stopped immediately.It was noted that patient's blouse around the port insertion site was wet.Blue barrier pad placed between patient's skin and wet blouse.Flushed huber using side port of needle set.Good blood return noted, flushed without issue and iv fluid started.Side port noted to be faulty and continued to leak iv fluid.Attempted to place alcohol cap on side port, but continued to leak.No holes or evident damage seen.Iv flush infusion stopped and port was de-accessed.Port re-accessed with new huber needle.Port site flushed with ns with no leaking noted.

• Brand Name: PORT ACCESS NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7780271
• MDR Text Key: 117018177
• Report Number: 7780271
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066214
• UDI-Public: (01)00801741066214
• 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
• Report Date: 07/24/2018

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: No Information
• Device Model Number: LH-0031YN
• Device Catalogue Number: LH-0031YN
• Device Lot Number: ASCSS0065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 86