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

Model Number	8888256503
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
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 the catheter has a hole.Additional information received on 23-dec-2019 stated that the hole prevented the device from suctioning and caused air to leak from the hole.There was no patient injury.
Additional Manufacturer Narrative
One photo was supplied by the customer and seven unused samples with lot numbers 1922500964 (2) 1926741964 (2) 1928839164 (3) were received for evaluation.Based on the photographs and after performing a visual inspection in the returned samples, the condition reported by our customer was not confirmed; the samples did not show any type of deficiency.The exact root cause could not be determined based on the returned samples/photos.Functional inspection is performed during the manufacturing process with acceptable results according with quality standard requirements.No corrective actions are deemed necessary at this time.The process is running according to product specifications meeting quality acceptance criteria the process will be continuously monitored for any adverse trends that require immediate attention.

• Brand Name: 2565 REPLOGLE CATH 10 FR
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9511827
• Report Number: 9612030-2019-02381
• Device Sequence Number: 2695373
• Product Code: BSY
• UDI-Device Identifier: 20884521102443
• UDI-Public: 20884521102443
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 1928839164
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1