MAUDE Adverse Event Report: SIMPLIVIA HEALTHCARE LTD ONGUARD 2 CSTD BAG ADAPTOR SP SPIKE PORT ADAPTOR; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number 412143

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

Onguard 2 cstd bag adaptor fits loosely inside 500-ml excel b braun bag and falls off the bag.The spike port was pushed all the way in but sill managed to fall off.This has occurred multiple times with the adapter and has been reported every time to the distributor, (b)(4).

• Brand Name: ONGUARD 2 CSTD BAG ADAPTOR SP SPIKE PORT ADAPTOR
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): SIMPLIVIA HEALTHCARE LTD
• MDR Report Key: 13602134
• MDR Text Key: 286370829
• Report Number: MW5107717
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 412143
• Device Lot Number: UBE518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCEL B BRAUN BAG