MAUDE Adverse Event Report: COVIDIEN BALLOON SLG 18FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	718150
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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 that all feeds pouring out around stoma.The nutriport was placed on (b)(6) 2020.When checked the tube under the top section where the shaft joins, there is a split in it.A new nutriport of same size has been replaced.There was no patient harm reported.
Additional Manufacturer Narrative
Additional information h4, h6 investigation summary one decontaminated sample without the original package or lot number was received for evaluation.Visual and functional inspections were carried out per procedure.The reported issue was confirmed; the sample presents a small crack in the part of the union of the tube to the nutriport, which causes it to slowly leak.The device history record file was reviewed indicating that the product was released meeting all quality standard requirements.The affected component is produced by an external supplier.Our assembly process consists of a pick and place operation only.At this time, the root cause is not known.An investigation request was sent to the supplier.It must be noted that each production lot is subjected to a 100% leak testing and inspection per procedure and all products shipped have passed inspection.Should there have been a manufacturing failure, it would have been detected during the product functionality testing and quality inspection.No adverse trends have been identified related to this issue.No corrective actions are planned at this time.The supplier regularly analyzes complaint data and trends and will take further actions accordingly.
Additional Manufacturer Narrative
The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on october 22, 2019.One decontaminated sample was received at the manufacturing site for evaluation.The sample arrived without the original package or lot number.Upon a visual and functional evaluation of the sample, the reported issue was confirmed; the sample presented a small crack in the part of the union of the tube to the nutriport, which causes it to slowly leak.The affected component is produced by an external supplier.Cardinal health¿s assembly process only consists of a pick and place operation for this material.As a result, an investigation request has been sent to the supplier to determine the root cause of the issue observed.The results of the supplier¿s investigation will be documented and shared when available.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 18FR X 1.5CM
• 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: 11230180
• Report Number: 9612030-2021-02784
• Device Sequence Number: 3805294
• Product Code: KNT
• UDI-Device Identifier: 10884521011120
• UDI-Public: 10884521011120
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 08/05/2021

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
• Operator of Device: No Information
• Device Model Number: 718150
• Device Catalogue Number: 718150
• Device Lot Number: 1928829364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 01/20/2021; 01/20/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/26/2021; 08/05/2021
• Patient Sequence Number: 1