MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. MCKESSON SELF-SEAL POUCH; STERILIZATION POUCHES

Model Number	73-SSP382
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility isolated all additional pouches identified with holes and reprocessed the instruments prior to use.Crosstex learned from discussion with user facility personnel that they were not properly folding the pouch seal on the perforated line where the holes were observed resulting in the reported event.Crosstex is not aware of any adverse clinical event associated with this incident and is filing this mdr because sterility of devices processed in the mckesson self-seal pouches cannot be guaranteed unless devices are processed in accordance with the instructions for processing and use.A review of complaints indicates this to be an isolated event.The user facility has discontinued use of the mckesson self-seal pouches.No additional issues have been reported.
Event or Problem Description
The user facility reported that there were holes in their mckesson self-seal pouches and the instruments sterilized in the pouches were subsequently used during patient procedures.The number of devices used is unknown.No report of injury.

• Brand Name: MCKESSON SELF-SEAL POUCH
• Common Device Name: STERILIZATION POUCHES
• Manufacturer (Section D): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd; rush NY 14543
• Manufacturer (Section G): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: daniel davy ; 6789 w henrietta rd.; rush, NY 14543 ; 4403927453
• MDR Report Key: 15551079
• Report Number: 1319130-2022-00005
• Device Sequence Number: 5959557
• Product Code: KCT
• UDI-Device Identifier: 20612479159369
• UDI-Public: 20612479159369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 73-SSP382
• Device Lot Number: 2022-06-30
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown