MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS 10PK CARTRG; M3

Catalog Number	33516
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
Event or Problem Description
This report is 2 of 2 for the cryosolutions cartridge reportedly used during this event and is related to manufacturer number: 3006697299-2024-00181.A facility reported that the device was leaking.The user reportedly changed to a new cryosolutions cartridge (33516) and as it was being screwed in to the cryosolutions pen, "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.
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
N/a.
Additional Manufacturer Narrative
The cryosolutions 10pk cartridge (33516) was not returned to the manufacturer for evaluation.The lot number provided by the customer is not a valid lot number; therefore, a review of the device history record (dhr) could not be reviewed.Thus, a definitive root cause could not be determined.The issue of leaking may be the result of a damaged/worn o-ring or issues with the cartridges.Investigation by the product's legal manufacturer/sales entity found that certain lots of cryosolutions cartridges were affected by a valve that may open prematurely.The legal manufacturer has provided a safety advisory and instructions for use (ifu) updates which have been distributed by integra to affected customers/distributors as part of a voluntary correction.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 10PK CARTRG
• Common Device Name: M3
• 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: 21107708
• Report Number: 3014334038-2025-00002
• Device Sequence Number: 8656609
• Product Code: GEH
• UDI-Device Identifier: 10381780171959
• UDI-Public: 10381780171959
• 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): 03/14/2025

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: 33516
• Device Lot Number: UNKNOWN
• 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: 02/17/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT AVAILABLE/CORRECTION
• Patient Sequence Number: 1
• Patient Sex: Unknown