MAUDE Adverse Event Report: COV LP/LLC, CRYSTAL LAKE, MFG; SYRINGE, IRRIGATING (NON DENTAL)

Model Number UNK NS

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem Burn(s) (1757)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way.Upon completion, the results will be forwarded.

Event Description

Customer reports: condensation inside syringe casing.When opened, the liquid has burned the skin of 3 individuals.Two subsequent complaints have been entered; one for each individual case.

Manufacturer Narrative

A review of the device history record was unable to be performed without a lot number.The method of root cause analysis that was implemented in this investigation was to conduct a process walk through while performing a six massessment to identify areas where liquid is introduced into the manufacturing process that could make its way inside the molded sleeve.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 insufficient mixing of vesta syde sq disinfectant and operator training for controlled manufacturing cleanliness.It is not clear from the information provided if the syringe was re-used.As indicated on the instructions for use provided, it is advised that syringes not be used if opened or damaged.A tamper evident seal is provided to determine if the syringe has been opened.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.A change order was completed to identify which department is responsible for vesta syde sq solution preparation and provide instructions on how to properly mix/dilute the cleaning agent.A training module was assigned to initiate retraining for all affected employees.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports: condensation inside syringe casing.When opened, the liquid has burned the skin of 3 individuals.Two subsequent complaints have been entered; one for each individual case.

• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• 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: 6682177
• MDR Text Key: 78903839
• Report Number: 1424643-2017-05010
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK NS
• Device Catalogue Number: UNK NS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: No
• 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