MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; EVACUATOR,400CC,PVC,10FR,1/8"

Catalog Number DYNJWE402

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that during removal, a piece of the evacuator broke off into the patient.When the broken evacuator was identified, the patient was taken to a procedure room where an arthrotomy was performed to remove the broken-off evacuator piece from the patient.No further medical intervention or follow-up care reported.No impact to the patient or the patient's stability reported.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the need for medical intervention to remove the broken-off evacuator piece from the patient, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that during removal, a piece of the evacuator broke off into the patient.

• Type of Device: EVACUATOR,400CC,PVC,10FR,1/8"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8151041
• MDR Text Key: 130042704
• Report Number: 1417592-2018-00125
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJWE402
• Device Lot Number: 96918070002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 72