MAUDE Adverse Event Report: WALKMED INFUSION, LLC.; INFUSION TUBE SET

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Device Issue (2379)

Patient Problems Chemical Exposure (2570); Patient Problem/Medical Problem (2688)

Event Date 11/21/2015

Event Type  malfunction  

Manufacturer Narrative

Due to the lack of information available by the patient, walkmed infusion is seeking to further investigate the tubing that may have been used at the time of the incident.The tubing was not returned to walkmed infusion and the lot number was not provided as the product was discarded by the user facility.

Event Description

During treatment, the patient called walkmed infusion's 24 hour customer support line because it was noticed that there was a small leak in the line.The patient stated he fixed the leak but some of the chemo medication leaked onto his hands and clothing.The call was addressed by walkmed infusion and trouble-shooted with the patient at the time of the incident.The patient then notified his doctor and the doctor had the patient tighten the connection between the port and the tubing.

• Type of Device: INFUSION TUBE SET
• Manufacturer (Section D): WALKMED INFUSION, LLC.; 6555 s. kenton st.; suite 304; centennial CO 80111
• Manufacturer (Section G): WALKMED INFUSION, LLC.; 6555 s. kenton st.; suite 304; centennial CO 80111
• Manufacturer Contact: arlana levin ; 6555 s. kenton st; suite 304; centennial, CO 80111 ; 3034209569
• MDR Report Key: 5316972
• MDR Text Key: 34075276
• Report Number: 1723533-2015-00043
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 60 YR