MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	716120
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
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 product is leaking distilled water from the balloon and causing the diet to leak on the patient's skin.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information h4 device manufacture date was added evaluation summary 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 reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated nutriport in its original packaging was received at the manufacturing site for evaluation.The returned sample did not have any damage visible to the naked eye but did show evidence of use.The complaint sample¿s balloon cuff was blousy and discolored.Evaluating the complaint sample under magnification did not reveal any cuts, tears, or score marks on the device that could propagate into a leak path.The balloon cuff was inflated with 5ml of air and a leak immediately occurred.To identify the leak path, the sample was leak tested.The void in the adhesive was isolated to one leak path that could then be seen under magnification.A proximal end cuff failure was confirmed.An exact root cause could not be determined.Each production lot is subject to a 100% leak testing and inspection and all product shipped passed this inspection.Should there have been a manufacturing issue, it would have been detected during the product functionality testing and quality inspection.According to the nutriport instructions for use (ifu), the exact balloon longevity cannot be predicted.As stated within the ifu, generally the silicone balloons last 1-8 months, but the life span of the balloon varies according to several factors.These factors may include medications, balloon fill volume, gastric ph, and tube care.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 16 FR X 1.2 CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12539912
• Report Number: 9612030-2021-03045
• Device Sequence Number: 20167933
• Product Code: KNT
• UDI-Device Identifier: 10884521010772
• UDI-Public: 10884521010772
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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 Model Number: 716120
• Device Catalogue Number: 716120
• Device Lot Number: 1802581464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown