MAUDE Adverse Event Report: COVIDIEN PED-TBE 6FR;20IN WGT W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884730741
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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 the probe has a hole in the distal part, which does not allow its correct operation for enteral nutrition.There was no harm to the patient.
Additional Manufacturer Narrative
Investigation conclusion the customer reported the probe has a hole in the distal part, which does not allow its correct operation for enteral nutrition.There was no reported harm to the patient.This reported issue occurred with product 8884730741, ped-tbe 6fr;20in wgt w/stylet, lot number 182260936, manufactured on 21-aug-2018.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Lot and failure mode trending was reviewed and no related adverse trends were identified.The reported device was not returned for evaluation; however, a video was submitted for evaluation.Visual inspection of the video confirmed the reported product issue as a leak was identified at the tube adapter.An investigation was initiated in sep-2018, after the reported product was manufactured, to determine the root cause of this confirmed product issue and corrective action(s) were implemented to prevent recurrence.Additional action is not necessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: PED-TBE 6FR;20IN WGT W/STYLET
• 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: 11826438
• Report Number: 9612030-2021-02901
• Device Sequence Number: 4242501
• Product Code: KNT
• UDI-Device Identifier: 30884521009619
• UDI-Public: 30884521009619
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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
• Operator of Device: No Information
• Device Model Number: 8884730741
• Device Catalogue Number: 8884730741
• Device Lot Number: 1822609364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1