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

Model Number	60ES
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the pediatric feeding extension set port (60es) disconnected from the extension tubing, leaving it unusable.No patient injury was reported.Additional information received on 26-mar-2021 stated that the entire port came off and there was leaking.The device needed to be replaced.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on march 18, 2020.One decontaminated sample from lot number 2007105064 was received at the manufacturing site for evaluation.Upon a visual and functional evaluation of the sample, the reported issue was confirmed; the disassembly of the tube to the adapter due to a lack of solvent was observed which caused the device to leak.During the investigation, a review through the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.The most likely root cause of this issue is due to a lack of solvent that was used by the operator when performing the assembly of the tube with the adapter.As part of continuous improvements, a notification has been sent to the manufacturing staff to heighten awareness of the reported condition.In addition, the employees have been retrained to the procedure and the inspection level has been changed to rigorous.These actions are designed to prevent the reported issue from reoccurring.No further corrective actions are applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: MICROBORE EXTENSION SET 60IN
• 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: 11576631
• Report Number: 9612030-2021-02828
• Device Sequence Number: 3598948
• Product Code: KNT
• UDI-Device Identifier: 20884521143910
• UDI-Public: 20884521143910
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 60ES
• Device Catalogue Number: 60ES
• Device Lot Number: 2007105064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 05/25/2021
• Patient Sequence Number: 1