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

Model Number LH-0031

Device Problems Break (1069); Contamination (1120); Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

Patient was discharged home on continuous chemotherapy (blinatumomab).Mom woke patient up and saw that he was lying in a pool of medication.Blood was coming out of his line.Mother was unaware of duration of line break.Patient arrived to clinic and line break was visualized proximal to the needless endcap.Line break was on safe step needle tubing.Patient is at risk for blood stream infections due to this line break along with contamination of chemotherapy medication in the home.Patient began block 2 of blinatumomab therapy and had been receiving the continuous infusion since.He was discharged after initiation of the medicine.He was having outpatient bag changes every 72 hours.He presented for his day 8 scheduled bag change.He was brought to clinic by father who reported that when he awoke that morning, he was found to have blood leaking from his port tubing and his drug had leaked onto his pajamas.Parents were not sure how long it had been leaking as it had occurred sometime during sleep but the best estimate based on remaining volume was that it leaked for 6 hours.He had continued to tolerate the infusion well and without side effects.Upon arrival to clinic, the leak was visualized to be proximal to the line end cap.His port was deaccessed and reaccessed and central and peripheral blood cultures were obtained.Vancomycin was infused through his reaccesed port over 2 hours.He was then admitted for observation after the blinatumomab infusion was resumed to monitor tolerance.His new blinatumomab bag was hung on the day of admission.He was monitored overnight and had no signs of side effects or intolerance.He remained afebrile.His central and peripheral cultures showed no growth x 24 hours.He was stable for discharge home.He was scheduled to return to the pediatric oncology clinic for his next bag change.

• 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: 16396255
• MDR Text Key: 309745222
• Report Number: 16396255
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LH-0031
• Device Catalogue Number: LH-0031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2023
• Event Location: Home
• Date Report to Manufacturer: 02/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1095 DA
• Patient Sex: Male