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

Model Number 8888505016

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2021

Event Type  Injury  

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.

Event Description

Customer reports: the distal portion ( approx.3 ½ inches) of the yankauer suction tip broke off in the patients femoral canal and was unable to be retrieved.

Manufacturer Narrative

Additional information received stated that the patient has been transferred to inpatient rehab and there will not be any additional surgery or medical intervention to remove the retained portion of the device.

Manufacturer Narrative

H3 evaluation summary a review of the device history record (dhr) could not be conducted because a lot number was not available.A piece of yankauer (7 "approximately) without the original packaging or lot number was received at the plant for evaluation.The sample was visually reviewed based on procedure and it was observed that the broken part of the yankauer has marks of damage, as if it had been forced with some metal.The manufacturing process was reviewed with the multifunctional team.Manufacturing process was reviewed.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.As well, there have been no similar cases detected in our manufacturing process for this failure mode in the past.Qc inspections are performed to the product for material release and production personnel perform a 100% visual inspection during the packaging process, in order to detect and discard any identified issues.Within the sample received the broken part of the yankauer was observed with marks of damage as if it had been forced with some solid instrument.This is a condition never seen before within the manufacturing process of this product, and there is no part of the process that can generate this type of damage.Per the investigation results previously described, it was concluded that the reported condition could not be confirmed to be manufacturing related.No action plan is deemed required.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.

• Brand Name: YANKAUER REGULAR CAPACITY BULB
• Type of Device: 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: 11723758
• MDR Text Key: 247238373
• Report Number: 9612030-2021-02874
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884527019946
• UDI-Public: 10884527019946
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2021

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
• Device Operator: No Information
• Device Model Number: 8888505016
• Device Catalogue Number: 8888505016
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 04/22/2021; 04/22/2021
• Supplement Dates FDA Received: 04/26/2021; 08/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other