MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. STEAM TAPE; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Model Number	ST-036
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The tape for sterile processing did not turn colors after sterilizing the trays as intended, to confirm sterility.Trays were re-opened and reprocessed as a precaution.All machine parameters had been met.Integrators inside the trays had passed.Some loads were processed with biological indicators, which had also passed.We pulled the lot number of the tape that we believed to be affected and ran a test.Tape from 2 different rolls of the same lot number had different results.1 was fine, 1 was not.We thought that it was just 1 bad roll.This morning there were several more trays that the tape did not look as dark, so we pulled and reprocessed those as well.We ran another test and we were not able to recreate the issue.We have now pulled all rolls with that lot number.This error is a good catch.It did not reach the patient or cause any harm.

• Brand Name: STEAM TAPE
• Common Device Name: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): SPSMEDICAL SUPPLY CORP.; 6789 west henrietta rd.; rush NY 14543
• MDR Report Key: 8860229
• Report Number: 8860229
• Device Sequence Number: 11284495
• Product Code: JOJ
• UDI-Device Identifier: 10732224730193
• UDI-Public: (01)10732224730193(10)9017(17)220131
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019
• Report Date (Section F): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: ST-036
• Device Catalogue Number: ST-036
• Device Lot Number: 9017
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/15/2019