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Model Number 8881512852
Device Problem Contamination (1120)
Patient Problem No Patient Involvement (2645)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record (dhr) was completed. The review reveled challenges during the manufacturing process while concluding that all acceptance criteria checks per established sampling levels were still within predefined limits prior to final release. A product analysis was unable to be completed as samples were unavailable for review. Without samples or pictures, the reported condition could not be observed. The method of root cause analysis that was implemented in this investigation was to conduct a six m assessment that evaluated causes. The most probable cause was identified as inherent vibration during manufacturing leading to printer entrance dial guide rail screws/bolts loosening over time which created syringe barrel jams/scratches and ultimately the potential for particulate. Based on the information available, no trend established and investigation findings, additional actions are deemed unnecessary at this time. A maintenance work order was completed to address the most probable root cause. Acceptance criteria per established levels are within acceptable limits. If additional information is received warranting further analysis, the investigation may be resumed? this complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Submit date: 12/28/2017. An investigation is currently underway. Upon completion, the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
Event Description
According to the customer, the syringe interior was coated with white powdery material.
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Manufacturer (Section D)
815 tek dr
crystal lake IL 60014 8172
Manufacturer (Section G)
815 tek dr
crystal lake IL 60014 8172
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
MDR Report Key7152176
MDR Text Key250921421
Report Number1424643-2017-05038
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881512852
Device Catalogue Number8881512852
Device Lot Number16MO2763X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown