MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ COMPLY¿ STERIGAGE¿; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Catalog Number	1243A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medwatch mw5087917 was received from the fda.Initial reporter's contact information was not provided to 3m.Patient information was not provided.Without a lot number, the expiration date and manufacture date could not be determined.Initial reporter's occupation not provided.3m was made aware of this event by the fda via medwatch mw5087917.The device was not returned for evaluation.The customer report did not provide a lot number.The customer did not elaborate on quantity or placement of devices in the tray which may provide an indication of the chemical integrator handling.A device history review (dhr) could not be performed without a lot number.Internal chemical integrators for steam sterilization process monitoring should be removed from the tray and inspected prior to instrument use.Customer procedures should refer to product 1243a instructions for use (ifu) documentation and process guidelines for best results.
Event or Problem Description
A pediatric patient underwent an uncomplicated ablation for wolfe parkinson white syndrome.Post-op in pacu, the patient reportedly coughed up a 3m¿ comply¿sterigage¿ steam chemical integrator.It was alleged that the indicator had worked its way into the laryngoscope blade and was silver side up.The patient was reportedly unharmed.
Additional Manufacturer Narrative
Product code was corrected to reflect (b)(4).End of report.

• Brand Name: 3M¿ COMPLY¿ STERIGAGE¿
• Common Device Name: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8906604
• Report Number: 2110898-2019-00095
• Device Sequence Number: 2151658
• Product Code: JOJ
• UDI-Device Identifier: 30707387469079
• UDI-Public: 30707387469079
• Combination Product (Y/N): N
• PMA/510(K) Number: K101249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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 Catalogue Number: 1243A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1