MAUDE Adverse Event Report: 3M COMPANY 3M¿ ATTEST¿; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Model Number 1243RE

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

Some of the internal integrators were not changing to black in the accept area.Other items in the same sterilizer integrators changed to black in the accept area however they were a different lot number.All 3 sterilizers were researched and the lot number on this item was the only lot number that was not progressing to the accept area.All sterilized items have been removed and reprocessed.The effected lot# sx092023 was removed.Manufacturer response for indicator, physical/chemical sterilization process, 3m¿ attest¿ (per site reporter).Representative from 3m was notified and stated he would file a product complaint.

Event Description

Some of the internal integrators were not changing to black in the accept area.Other items in the same sterilizer integrators changed to black in the accept area however they were a different lot number.All 3 sterilizers were researched and the lot number on this item was the only lot number that was not progressing to the accept area.All sterilized items have been removed and reprocessed.The effected lot# sx092023 was removed.
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manufacturer response for indicator, physical/chemical sterilization process, 3m¿ attest¿ (per site reporter)
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representative from 3m was notified and stated he would file a product complaint.

• Brand Name: 3M¿ ATTEST¿
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 12915739
• MDR Text Key: 281590614
• Report Number: 12915739
• Device Sequence Number: 1
• Product Code: JOJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1243RE
• Device Catalogue Number: 1243RE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1