MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP; M3-DERMAL

Catalog Number	33510
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
This report is 1 of 2 for the cryosolutions set with 1 cartridge (33510) reportedly used during this event and is related to manufacturer number: 3014334038-2025-00002.A facility reported that the device was leaking.The user reportedly changed to a new cartridge and as it was being screwed in to the cryosolutions pen from the cryosolutions set with 1 cartridge (33510), "it released all the nitro in a single burst freezing the device and the gloves." there was no patient involvement nor injury to the user.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cryosolutions set with 1 cartridge (33510) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; device history records (dhr) were reviewed, and no abnormalities related to the reported issue were identified.Therefore, a definitive root cause of the reported issue could not be determined.The product serial number indicates a manufacture date of 2015.The issue of leaking may be the result of a damaged/worn o-ring or issues with the cartridges.Certain lots of cryosolutions cartridges were identified to have valve issues by the product's legal manufacturer.A safety advisory and voluntary correction were initiated by integra and the legal manufacturer.Affected customers have received a letter providing guidance and an updated instructions for use (ifu).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 SET WITH 1 CARTRIDGE/1MM TIP
• Common Device Name: M3-DERMAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21107709
• Report Number: 3006697299-2024-00181
• Device Sequence Number: 20996834
• Product Code: GEH
• UDI-Device Identifier: 10381780171898
• UDI-Public: 10381780171898
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 33510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CRYOSOLUTIONS 10PK CARTRG 33516.
• Patient Sex: Unknown