MAUDE Adverse Event Report: CARDINAL HEALTH DON HASKINS KIT, ANESTHESIA (8752A)686; KIT, ANESTHESIA / LRO

Model Number	AN1428752B
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	08/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record (dhr), for lot number 1600435-sh, did not show any exception that was recorded in the dhr that could have led to the reported incident.A 100% inspection of similar products in the warehouse was conducted without finding any issues with the product.A review of the historical trend, for this product showed that this is the first reported incident for the past 12 months.  a 100% inspection has been implemented in the process in an effort to eliminate this type of issue.The actual failed sample was not been provided, therefore we are unable to conduct further analysis and confirm the exact cause of the failure reported.Relevant personnel have been informed of this report in an effort to raise awareness.Based n the information provided at this time no additional action taken will be taken at this time, however, we will continue to monitor the trend for this type of incident.If the defective product is returned in the future, a follow-up report will be filed and an investigation will be reopened to evaluate the returned sample.
Event or Problem Description
Based on the customers report the issue with the mask was that they had a very large gentleman with a beard who desaturated quickly after induction of general anesthesia.During ventilation they were having difficulty which was partly due to the mask being "flat".They were able to ventilate and get his spo2 up again before intubating him.They obtained a replacement mask during the episode.Upon there inspection of the mask after the incident, they found the parts of the inflation valve inside the inflatable rim of the mask.The resident on the case stated that she had inflated the mask during the machine check; in fact, she states that this is standard for her since the masks often seem to be "flat" when they come out of the package.I can not be sure if the valve was damaged prior to the case or if it could have been damaged by someone inserting a syringe into the valve to inflate it.

• Brand Name: KIT, ANESTHESIA (8752A)686
• Common Device Name: KIT, ANESTHESIA / LRO
• Manufacturer (Section D): CARDINAL HEALTH DON HASKINS; 1320 don haskins; el paso TX 79936
• MDR Report Key: 5923233
• Report Number: 1423537-2016-00040
• Device Sequence Number: 11140383
• Product Code: LRO
• UDI-Device Identifier: 10887488334745
• UDI-Public: 10887488334745
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: AN1428752B
• Device Catalogue Number: AN1428752B
• Device Lot Number: 1600435-SH
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 09/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Weight: 135