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

Catalog Number	33517
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cryosolutions 4pk cartridge (33517) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.The returned cartridges (33517) were in used condition.Investigation by the product legal manufacturer/sales entity, nmt/ump, found that this lot of 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.
Event or Problem Description
A facility reported that the cylinders of the cryosolutions 4pk cartridge (33517) "burst the nitrous oxide (n20) as they were getting placed".It is unknown whether there was patient involvement; however, no injury, death or surgical delay was reported.
Additional Manufacturer Narrative
Updated fields: g3, g6, d9, h2, h11.Corrected field: h9.
Event or Problem Description
N/a.

• Brand Name: CRYOSOLUTIONS 4PK 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: 22391769
• Report Number: 3014334038-2025-00095
• Device Sequence Number: 9017437
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 33517
• Device Lot Number: C6741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 96067
• Patient Sequence Number: 1
• Patient Sex: Unknown