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

Catalog Number	33516
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 2 reports for the cryosolutions cartridge used during this event and is linked to mfg number 3014334038-2024-00032.It was reported that a physician was burned when handling the cryosolutions 10pk cartridge (33516).Staff was using a new lot of cartridges and one exploded with liquid nitrogen when applying a new cartridge to the cryopen.It is unknown whether medical intervention was required.No patient injury or surgical delay has been reported.
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.
Additional Manufacturer Narrative
Updated fields: d4 (udi#), d9, g3, g6, h2, h3, h6, h10, h11.Corrected field: d4 (product serial number).The suspected product/cryosolutions 10pk cartrg (33516) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.A definitive root cause of the reported issue could not be determined.The issue of gas exploding or spraying out may result from misalignment of the cartridge and control mechanism during setup, or a damaged o-ring.The instructions for use (ifu) directs the user to "always use protective gloves when installing cartridges and using cryosolutions devices".Poor alignment of the cartridge and control mechanism may allow gas to escape.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.Corrective and preventative actions was opened to investigate the issue of providers being burned by cryosolutions.
Event or Problem Description
N/a.

• Brand Name: CRYOSOLUTIONS 10PK CARTRG
• 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: 18727449
• Report Number: 3014334038-2024-00020
• Device Sequence Number: 5741600
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 33516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/16/2024
• 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