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

Model Number 73-SSP382

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 303650711
• Report Number: 1319130-2022-00005
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 20612479159369
• UDI-Public: 20612479159369
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 73-SSP382
• Device Lot Number: 2022-06-30
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1