MAUDE Adverse Event Report: COVIDIEN SUCTION YANKAUER CLEAR BULB TIP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	K86
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported the tip was broken off the top of the suctions catheter and not present in the unopened package.
Additional Manufacturer Narrative
A product analysis was unable to be completed as to date no samples or pictures have been provided.Precluding any further information or evidence there is not enough information at this time to determine with any confidence what likely caused the reported issue; therefore, the root cause is undetermined.However, due to previous evaluation on samples reported with a similar condition the potential root cause may be attributed to the use the device to pry apart anatomy (organ manipulation) causing the tip to break.A production notification was issued to all personnel to heighten awareness of the condition reported by the customer.Since the current process was found to be running according to approved specifications and standard operation procedures and the product history demonstrates that the device is durable, safe and effective, no actions are needed at this time at the manufacturing facility.The product is inspected routinely to ensure that all product specifications are met.No additional risks controls have been applied as the current risk controls are sufficient and residual risks deemed to be negligible.

• Brand Name: SUCTION YANKAUER CLEAR BULB TIP
• 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: 8604707
• Report Number: 9612030-2019-02174
• Device Sequence Number: 3236794
• Product Code: GCX
• UDI-Device Identifier: 00885380030157
• UDI-Public: 00885380030157
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: No Information
• Device Model Number: K86
• Device Catalogue Number: K86
• Device Lot Number: 1833104764
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1