MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 5 FR X 20; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461412
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 the hub separated from the tubing.
Additional Manufacturer Narrative
During the device history record review it was noticed that the reported lot number belongs to product 461412 not the reported product 461420.The following sections were updated: d1 brand name, d4 model number, d4 catalog number, d4 udi #.The investigation findings are below: there were no physical samples or pictures submitted with this complaint report.Complaint shall be reopened if a sample is received.The lot number reported by the customer, 1910643264, does not correspond to product 461420.The lot number 1910643264 corresponds to product 461412.The device history record (dhr) files were reviewed and no discrepancies were found according to the failure mode reported.Since no physical sample was received for this report; the root cause of the reported condition stated by the customer could not be determined.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria.We will be keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: POLYUR FEED TUBE 5 FR X 20
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9312716
• Report Number: 9612030-2019-02352
• Device Sequence Number: 11295516
• Product Code: KNT
• UDI-Device Identifier: 10884521067936
• UDI-Public: 10884521067936
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 461412
• Device Catalogue Number: 461412
• Device Lot Number: 1910643264
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1