MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. STERILCONTAINER FILTER

Model Number US751

Device Problem Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation of the reported event is in process; a follow-up mdr will be submitted when additional information becomes available.The lot numbers subject of the reported event are 2308007, 2308001, 2307004, 2304001, 2301003, 2301006, and 2211003.

Event Description

The user facility reported tiny holes were identified in their container filters causing procedure delays.The user facility confirmed the instruments were re-sterilized prior to use.No report of injury.

Manufacturer Narrative

Crosstex has made multiple attempts to obtain additional information from the customer regarding the reported event.To date, we have not received a response.As no additional information was provided regarding the reported event, a root cause could not be determined.Crosstex will continue to monitor for similar events.No additional issues have been reported.

• Brand Name: STERILCONTAINER FILTER
• Type of Device: STERILCONTAINER FILTER
• 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 west henrietta rd.; rush, NY 14543 ; 4403927453
• MDR Report Key: 18160989
• MDR Text Key: 328416133
• Report Number: 1319130-2023-00012
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 04038653473731
• UDI-Public: 04038653473731
• 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,Followup
• Report Date: 11/17/2023

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
• Device Operator: Health Professional
• Device Model Number: US751
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 02/19/2024
• Date Device Manufactured: 11/01/2022
• 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