CROSSTEX SPS MEDICAL SPORVIEW CULTURE SET CS-020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for CROSSTEX SPS MEDICAL SPORVIEW CULTURE SET CS-020 manufactured by Sps Medical Supply Corp. A Division Of Crosstex.

Event Text Entries

[174672088] Specifics are: crosstex sps sporview culture set. Turbidity, color change, in spore tests incubation vials culture set from the manufacturer, prior to exposure to pathogen. -cat no. Cs-020. Lot 639. -vials identified in 2 boxes with same batch #. -number of vials that appear contaminated: 5. -expiration 30 sep 2020. A previous report with a similar issue was completed around 27, july 2018 to the fda (lot 580). Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092133
• MDR Report Key: 9569782
• Date Received: 2020-01-08
• Date of Report: 2020-01-06
• Date of Event: 2020-01-06
• Date Added to Maude: 2020-01-09
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CROSSTEX SPS MEDICAL SPORVIEW CULTURE SET
• Generic Name: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Product Code: FRC
• Date Received: 2020-01-08
• Catalog Number: CS-020
• Lot Number: 639
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX

Device Sequence Number: 2

• Brand Name: CROSSTEX SPS MEDICAL SPORVIEW CULTURE SET
• Generic Name: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Product Code: FRC
• Date Received: 2020-01-08
• Catalog Number: CS-020
• Lot Number: 639
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX

Device Sequence Number: 3

• Brand Name: CROSSTEX SPS MEDICAL SPORVIEW CULTURE SET
• Generic Name: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Product Code: FRC
• Date Received: 2020-01-08
• Catalog Number: CS-020
• Lot Number: 639
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: SPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX

Device Sequence Number: 4

• Brand Name: CROSSTEX SPS MEDICAL SPORVIEW CULTURE SET
• Generic Name: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Product Code: FRC
• Date Received: 2020-01-08
• Catalog Number: CS-020
• Lot Number: 639
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: SPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX

Device Sequence Number: 5

• Brand Name: CROSSTEX SPS MEDICAL SPORVIEW CULTURE SET
• Generic Name: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Product Code: FRC
• Date Received: 2020-01-08
• Catalog Number: CS-020
• Lot Number: 639
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: SPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-08