MAUDE Adverse Event Report: BTG FARNHAM RADIOPAQUE EMBOLIC BEAD 70-150 MIC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	RO2L001
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contaminate was found in the vial.Contaminate was found in the vial prior to loading the radiopaque embolic bead 70-150 mic with chemotherapy agent.The vial/beads were not used in a procedure.
Event or Problem Description
It was reported that contaminate was found in the vial.Contaminate was found in the vial prior to loading the radiopaque embolic bead 70-150 mic with chemotherapy agent.The vial/beads were not used in a procedure.
Additional Manufacturer Narrative
Device analysis was performed.Returned product consisted of a lc bead shelf box and vial.The shelf box was opened prior to receipt.The vial was examined under a microscope and was unable to confirm the reported event of foreign matter in the vial.

• Brand Name: RADIOPAQUE EMBOLIC BEAD 70-150 MIC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BTG FARNHAM; two scimed place; farnham, surry MN GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; surrey GU98Q L; UK GU98QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12746583
• Report Number: 2134265-2021-13729
• Device Sequence Number: 4470943
• Product Code: KRD
• UDI-Device Identifier: 05060116921151
• UDI-Public: 05060116921151
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K152157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: RO2L001
• Device Catalogue Number: RO2L001
• Device Lot Number: 7004154-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown