MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 12FR;43IN W/STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711253E

Device Problem Crack (1135)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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 they noticed a crack in a nasoenteral tube.No patient injury was reported.

Event Description

The customer reported that they noticed a crack in a nasoenteral tube.No patient injury was reported.Additional information provided on 23-jun-2021 stated that the issue is with the purple y-port cracking, not the feeding tube part.

Manufacturer Narrative

Clarification of the incident was received on 23-jun-2021.Based on the clarification received, this incident does not meet the criteria of a reportable malfunction.No further follow up reports will be forwarded.Section b5 describe event or problem was updated.

• Brand Name: DOBBHOFF 12FR;43IN W/STYLET EN
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12046689
• MDR Text Key: 258716586
• Report Number: 9612030-2021-02960
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: 10884521582927
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Patient Sequence Number: 1