MAUDE Adverse Event Report: COVIDIEN MICROBORE EXTENSION SET 60IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 60ES

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation because it was 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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the tubing has a blockage at the male adaptor side and will not let the formula/milk pass through into feeing tube.The customer also stated that the connection to the feeding tube has been difficult.No patient injury was reported.

• Brand Name: MICROBORE EXTENSION SET 60IN
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11616455
• MDR Text Key: 243910820
• Report Number: 9612030-2021-02841
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20884521143910
• UDI-Public: 20884521143910
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2021

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
• Device Operator: No Information
• Device Model Number: 60ES
• Device Catalogue Number: 60ES
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1