MAUDE Adverse Event Report: EQUASHIELD LLC EQUASHIELD FEMALE LUER LOCK CONNECTOR - SWIVEL (FC-1S); CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number FC-1S

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2020

Event Type  malfunction  

Event Description

Caregiver in the home noticed blood pooling on patient's shirt during home infusion.Caregiver assessed the iv infusion, noticed where the home-pump c-series of fluorouracil iv medication connected to the cstd (equashield female luer lock connector-swivel (fc-1s)) had disconnected from each other and was bleeding from the cstd.Caregiver called home infusion company immediately to report event.Home infusion rn arrived at patient's home within 40 minutes to assess the situation.Caregiver had re-connected home-pump and cstd prior to rn arriving.Rn noticed that it looked like the home-pump and cstd had come apart again and tightened that connection again.Rn did not reconnect iv medication back to patient, instead rn aspirated iv assess and removed port-a-cath needle.Rn then returned supplies back to home infusion pharmacy.Fda safety report id# (b)(4).

• Brand Name: EQUASHIELD FEMALE LUER LOCK CONNECTOR - SWIVEL (FC-1S)
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD LLC
• MDR Report Key: 10086679
• MDR Text Key: 192151003
• Report Number: MW5094650
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC-1S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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: 55 YR
• Patient Weight: 119