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

Model Number 8884711253

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

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.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 Description

The customer reported kinking of the tube while in use.There was no harm to the patient.

Manufacturer Narrative

Correction h 6 device code updated to 2981 material twisted/bent.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The investigation was conducted with the multifunctional team.The manufacturing process was reviewed.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed during the manufacturing of this product.There were no abnormal conditions found that could trigger the reported condition; the current process is running according to approved specifications.In addition, qc inspections are performed to the product for material release; and production personnel performs a 100% visual inspection during the packaging process, in order to detect and discard any identified issue; should there have been a manufacturing issue it would have been detected during these process controls.A picture was provided for the evaluation.Upon analysis, an elbowing probe can be observed, however, quality specifications compliance of the product could not be determined from the provided picture.A physical sample is required to perform an appropriate inspection.Therefore, the reported issue was not confirmed to be generated from the manufacturing site.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: DOBBHOFF 12FR;43IN W/STYLET
• 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: 10547815
• MDR Text Key: 207361426
• Report Number: 9612030-2020-02618
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• 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,Followup
• Report Date: 01/28/2021

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: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2002101564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 09/10/2020
• Supplement Dates FDA Received: 09/17/2020; 01/28/2021
• Patient Sequence Number: 1