MAUDE Adverse Event Report: COVIDIEN BALLOON SLG 16FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	716200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
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 fluid is gushing out of the device when the extension set it removed.Additional information received stated the valve has stopped working so when they detach the extension set, anything in the stomach flows out.Immediately after a feed the formula that has just been administered comes out.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information.H4 date of manufacture added.H3 evaluation summary; the device history record (dhr) review showed 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 sample with the reported lot number was received at the manufacturing site for evaluation.The sample was visualized according to procedure.The balloon was filled with 2.0cm and no leakage was observed.The balloon was left with water for one day and when measured the next day, the amount of water was less than 1.5 cm.This product is provided by a supplier, so a supplier corrective action was created to further investigate.The action plan will be addressed under the supplier corrective action.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 16FR X 2.0CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; 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: 12518492
• Report Number: 9612030-2021-03042
• Device Sequence Number: 4230940
• Product Code: KNT
• UDI-Device Identifier: 10884521011007
• UDI-Public: 10884521011007
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 716200
• Device Catalogue Number: 716200
• Device Lot Number: 2100532464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown