MAUDE Adverse Event Report: BIOCOMPATIBLES U.K. LIMITED DC BEAD; EMBOLIC AGENT, HCG, KRD

Model Number 300-500UM

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/23/2015

Event Type  malfunction  

Event Description

This is a potential harm report rec'd from a tech via a partner organization.No procedure or pt info was provided.The report concerns an event reported post tace procedure using dc bead loaded with doxorubicin where the radiology department reported that the vial was found to contain a blue particulate.It was confirmed by the reporter that at the time of reporting the prod had already had the radio contrast added and the beads removed and injected into the pt.The reporter stated that during the procedure the blue contaminate kept getting stuck in the stopcock used to transfer the beads and drug prod.It was confirmed during the investigation that the blue containment observed in the syringe containing beads and doxorubicin solution was a fragment of a dilator which was inadvertently introduced into the prod during preparation procedure by the hospital personnel.There was no pt harm as a result of this incident.

Manufacturer Narrative

Dc bead with doxorubicin was reported to have been used in the treatment of this pt.The equivalent prod, lc bead, is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The device has not been sent to the mfr for eval.Med assessment: whilst there was no report of pt harm it was confirmed that the particulate was likely introduced during prod preparation and therefore this is user error and needs to be reported because if this type of error were to recur it could result in serious pt harm.Investigation into this report found that the blue contaminant observed in the syringe containing beads and doxorubicin solution was a fragment of a dilator which was inadvertently introduced into the prod during preparation procedure by the hospital personnel.

• Brand Name: DC BEAD
• Type of Device: EMBOLIC AGENT, HCG, KRD
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; weydon ln; farnham business park; farnham, surrey GU9 8QL; UK GU9 8QL
• Manufacturer Contact: sam temple-scotton ; weydon lane; farnham business park; farnham, surrey GU9 8-QL ; UK GU9 8QL ; 252732732
• MDR Report Key: 4811861
• MDR Text Key: 5928748
• Report Number: 3002124545-2015-00026
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: 300-500UM
• Device Lot Number: V10406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other