MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS 1PK CARTRGE; M3

Catalog Number	33518
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that three of the cryosolutions 1pk cartridge (33518) were leaking.It is unknown under what circumstance this event occurred; however, no injury, death or surgical delay was reported.It is noted that the reporting facility is a veterinary center.
Additional Manufacturer Narrative
The cryosolutions 1pk cartridge (33518) was not returned to the manufacturer; therefore, evaluation of the product could not be performed.At this time, it is unclear whether the issue reported is for item prod id 33518 (single pack) or 33516 (10 pack).Additional investigation by the product legal manufacturer/sales entity, nmt/ump, found that lots of 33516 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 1PK CARTRGE
• 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: 22391768
• Report Number: 3014334038-2025-00093
• Device Sequence Number: 13016097
• Product Code: GEH
• UDI-Device Identifier: 10381780171973
• UDI-Public: 10381780171973
• 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
• Report Date (Section B): 07/02/2025

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: Other
• Device Catalogue Number: 33518
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 07/02/2025
• 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