MAUDE Adverse Event Report: COVIDIEN 12FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461243E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the purple hub on the feeding port broke off.For a few days it was loose and the customer kept putting it back on as they didn't realize it wasn't a removable piece.There was no patient injury.

• Brand Name: 12FR 43 IRIS FEEDING TUBE ENF
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10541185
• Report Number: 1282497-2020-09450
• Device Sequence Number: 2962086
• Product Code: PIF
• UDI-Device Identifier: 20884521742229
• UDI-Public: 20884521742229
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 09/16/2020

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: 461243E
• Device Catalogue Number: 461243E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/16/2020
• Patient Sequence Number: 1