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

Catalog Number 1243A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Not Applicable (3189)

Event Date 06/21/2019

Event Type  malfunction  

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 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.

Manufacturer Narrative

Product code was corrected to reflect (b)(4).End of report.

• Brand Name: 3M¿ COMPLY¿ STERIGAGE¿
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY FLEMINGTON PLANT; 500 us-202; flemington NJ 08822
• Manufacturer Contact: dianne gibbs ; 2510 conway ave; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8906604
• MDR Text Key: 163021634
• Report Number: 2110898-2019-00095
• Device Sequence Number: 1
• Product Code: JOJ
• UDI-Device Identifier: 30707387469079
• UDI-Public: 30707387469079
• Combination Product (y/n): N
• PMA/PMN Number: K101249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1243A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1