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 underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports: condensation was inside the syringe casing and when opened, the liquid has burned the skin of 3 individuals.

Manufacturer Narrative

A review of the device history record was unable to be performed without a lot number provided by the customer.A lot will not be released unless all acceptance criteria inspections per established sampling levels are within acceptable limits.In the event of a failure during the manufacturing process, the most probable root cause is insufficient mixing of vesta syde sq disinfectant and operator training for the controlled manufacturing cleanliness process.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.In accordance with medical safety review, the severity for this incident is a level 1.At this point, a trend has not been established.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.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 and retraining for all affected employees was conducted as a corrective action.If information is provided in the future, a supplemental report will be issued.

Event Description

Condensation was inside the syringe casing and when opened, the liquid has burned the skin of 3 individuals.

• 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: 6682385
• MDR Text Key: 78896946
• Report Number: 1424643-2017-05011
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• 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