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

Model Number	K86
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/14/2019
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 that upon inspection, they found out that the device was damaged/broken.
Additional Manufacturer Narrative
H 3: evaluation summary: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Five pictures and one sample were received and evaluated.The photos and sample received show a yankauer broken into its original packaging.The reported condition was confirmed.According to the investigation, it was found that the device was not sorted correctly during manufacturing.The non conformance corresponds to the root cause of the manifold mold being dirty.A production notification was performed to all personnel to ensure that they are aware of the condition reported by the customer.Brainstorming and a fishbone analysis were performed.Cleaning of the manifold in the mold was recorded through the preventive maintenance work order.This complaint will be used for tracking and trending purposes.

• 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: 8911927
• Report Number: 9612030-2019-02251
• Device Sequence Number: 19234066
• Product Code: GCX
• UDI-Device Identifier: 00885380030157
• UDI-Public: 00885380030157
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 02/24/2020

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: 1724836664
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1