MAUDE Adverse Event Report: CARDINAL HEALTH 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	Foreign Body In Patient (2687)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: during a total hip replacement the bulbous tip of the yankauer suction handle broke off in the femoral canal and was unable to be removed.
Additional Manufacturer Narrative
A review of the device history records (dhr) yielded no discrepancies within the manufacture of the affected lot number reported.All quality assurance testing performed during manufacturing was acceptable.A sample analysis could not be performed since no photo samples nor actual sample device was received for evaluation.The root cause could not be determined without a sample to evaluate.Current controls include a 100% visual inspection by production personnel according to the standard work instruction for yankauer bulk products to inspect for damaged and broken components.In addition, a quality control sampling inspection is performed to ensure that product complies with the visual inspection of damage/broken components.In-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant are in place to prevent nonconforming product from leaving the manufacturing operations.Based on the assessment, no further actions are being pursued as a result of this event.

• Brand Name: SUCTION YANKAUER CLEAR BULB TIP
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15464181
• Report Number: 9612030-2022-03396
• Device Sequence Number: 6902732
• Product Code: GCX
• UDI-Device Identifier: 00885380030157
• UDI-Public: 00885380030157
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: Health Professional
• Device Model Number: K86
• Device Catalogue Number: K86
• Device Lot Number: 2208302664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW0300060000-2022-8006
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male