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	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report is 1 of 2 for the cryosolutions pen used during this event and is linked to mfg number 3014334038-2024-00136: a facility reported that the user tried to connect a new cartridge to the cryosolutions pen/cryosolutions set with 1 cartridge/1mm tip (33510) and the contents of the cartridge started spilling/spewed out.The customer suspects that the defect is the pen.It was reported that no patient injury occurred.
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
The cryosolutions set with 1 cartridge/1mm tip (33510) was not returned for evaluation after several good faith effort attempts have been made to retrieve the product; therefore, and evaluation of the device could not performed.The device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.The product serial number indicates a manufacture date of 2019.Damage to the o-ring may occur due to wear over multiple years of use.Gas can also escape if a new cartridge is installed incompletely.The cartridge must be screwed in quickly and completely.Protective gloves must always be worn when handling cryosolutions products.A definitive root cause of the reported issues could not be determined.If addition 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: 19611633
• Report Number: 3014334038-2024-00126
• Device Sequence Number: 20368617
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 33510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• 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