MAUDE Adverse Event Report: STERIS CORPORATION - HOPKINS VERIFY; VERIFY INDICATOR TAPE

Model Number	PCC071
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The verify indicator tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or light.The device history record for the subject lot was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A complaint review indicates this is an isolated event for the subject lot.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting an mdr solely due to the receipt of the user facility vigilance report which is in accordance with our policies and procedures.No additional issues have been reported.
Event or Problem Description
The user facility reported via a vigilance report to the italian ministry of health that their indicator tape was detaching from the sterile barrier system during the sterilization phase and the tape did not change completely.The user facility reported that the devices were reprocessed prior to use.No report of injury.

• Brand Name: VERIFY
• Common Device Name: VERIFY INDICATOR TAPE
• Manufacturer (Section D): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4403927453
• MDR Report Key: 20919922
• Report Number: 3000251274-2024-00005
• Device Sequence Number: 5118611
• Product Code: JOJ
• UDI-Device Identifier: 10724995172593
• UDI-Public: (01)10724995172593(17)250606(10)22224
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K231488
• 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): 12/12/2024

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 Expiration Date: 06/06/2025
• Device Model Number: PCC071
• Device Catalogue Number: PCC071
• Device Lot Number: (10)22224
• 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: 11/27/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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