MAUDE Adverse Event Report: COV LP/LLC, CRYSTAL LAKE, MFG MONOJECT; SYRINGE, PISTON

Model Number 8881112059

Device Problems Bent (1059); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/29/17.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer reports that there is a defect in the syringe connector.The customer states that the syringe is bent on the tip, with two impressions opposite each other on the shaft of the tip.Additionally, the customer reports that there are missing or inaccurate graduation marks.

Manufacturer Narrative

One sample was submitted for evaluation.It was not in its original supplied packaging.The reported conditions were observed.Based on the sample review it is clear in that a jam occurred during the printing operation which damaged the barrel and cause skewed printing.A review of the device history record (dhr) was completed for lot 15g09363x.The dhr was review showed no abnormal process conditions present during the manufacturing of this product that would lead to the reported conditions.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process, inclusive of running using validated process settings.The method of root cause analysis that was implemented in this investigation was to conduct a six m assessment.The assessment evaluated potential causes: man, material, method, measurement, machine, and mother nature (environment).The significant causes are noted and addressed in the corrective and preventative action section as appropriate.The most probable root cause is that a printer machine jam damaging the component and the process was incorrectly started back up following the jam.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.However, it is noted that an improved standard work order was put in place for line printer start up operations after production of the reported lot.If additional information is received warranting further analysis, the investigation will 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.

Event Description

The customer reports the defect is in the syringe connector.Visual observation found the syringe to be bent or crimped on the slip fit tip, with two impressions opposite each other on the shaft of the tip.There was some transverse scratching on the syringe barrel, and the printing on the syringe was deformed and incomplete.There were missing or inaccurate graduation marks.

• Brand Name: MONOJECT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer (Section G): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6905630
• MDR Text Key: 87856901
• Report Number: 1424643-2017-05026
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881112059
• Device Catalogue Number: 8881112059
• Device Lot Number: 15G09363X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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