MAUDE Adverse Event Report: 2565 REPLOGLE CATH 10 FR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	8888256503
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 catheter was received without any markings on it.There was no patient injury.
Additional Manufacturer Narrative
Section d4 has been updated to display the correct lot number of 1930933964 rather than 1930933064.
Additional Manufacturer Narrative
A device history record file was reviewed, and no discrepancy was found according to the reported condition.One decontaminated sample with lot number 1930933964 was received for evaluation.After performing a visual inspection based on the product specifications; missing depth marks can be observed.The reported condition is confirmed.The analysis was performed by a multi-functional team and it revealed that the condition of missing depth marks is due to a workmanship issue.When the device is missing marks, it is a condition generated when an operator fails to complete an impression or following the predetermined process steps to assure a complete impression.The rate of occurrence for the reported issue was evaluated against the acceptable quality limit (aql) guidelines and the results are that no action plan is required because the complaint represents a deficiency rate of 0.015%, which is below the approved aql of 0.65%.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: 2565 REPLOGLE CATH 10 FR
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• MDR Report Key: 10626818
• Report Number: 9612030-2020-02638
• Device Sequence Number: 2604181
• Product Code: BSY
• UDI-Device Identifier: 10884527006427
• UDI-Public: 10884527006427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2020

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: 8888256503
• Device Catalogue Number: 8888256503
• Device Lot Number: 1930933964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020; 09/29/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 10/07/2020; 11/24/2020
• 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: N
• Patient Sequence Number: 1