MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS 4PK CARTRGE; M3

Catalog Number	33517
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.E1: full name of reporting facility is (b)(6).
Event or Problem Description
This report is 1 of 2 for the cartridge used during this event and is linked to mfg number 3014334038-2024-00042.A facility reported that before a procedure, when the end user started screwing a cartridge of the cryosolutions 4pk cartridge (33517).Gas spilled out and froze the user's hands.The user experienced redness and tenderness to hands.Observation was performed.The cartridges were collected by the product distributor.
Additional Manufacturer Narrative
Updated fields: d4 (udi#).The suspected cryosolutions 4pk cartrge (33517) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.As a result, a definitive root cause cannot be determined.The issue of gas exploding or spraying out may result from misalignment of the cartridge and control mechanism during setup.Instructions for use (ifu) directs user to "always use protective gloves when installing cartridges and using cryosolutions devices.The cartridge must be screwed into the control mechanism in a clockwise direction both quickly and completely.The pin must be fully inserted into the pin insertion point before attaching the cartridge.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CRYOSOLUTIONS 4PK CARTRGE
• Common Device Name: M3
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18794052
• Report Number: 3014334038-2024-00035
• Device Sequence Number: 12595432
• Product Code: GEH
• UDI-Device Identifier: 10381780171966
• UDI-Public: 10381780171966
• Combination Product (Y/N): N
• PMA/510(K) Number: K091721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 33517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown