MAUDE Adverse Event Report: COVIDIEN HANDLE FLEXICLEAR REG CAPACITY; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	K61
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record (dhr) could not be conducted because a lot number was not provided.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were no physical samples or pictures submitted with this complaint report.Complaint shall be reopened if a sample is received.Since the sample has not been received for evaluation; conditions reported could not be confirmed and the root cause cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness at this time.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.
Event or Problem Description
The customer reported that the box looks just fine, but nearly every yankauer suction handle is mangled/bent/broken in half and poking out of the package.

• Brand Name: HANDLE FLEXICLEAR REG CAPACITY
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12242306
• Report Number: 9612030-2021-03007
• Device Sequence Number: 14492599
• Product Code: GCX
• UDI-Device Identifier: 00885380030171
• UDI-Public: 00885380030171
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: No Information
• Device Model Number: K61
• Device Catalogue Number: K61
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1