MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	714120
Medical Device Problem Codes	Fluid/Blood Leak (1250); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
As reported by the customer: the device had to be replaced due to a leak in the balloon which was possibly due to a rupture.Additional information provided on 2/25/22 stated that after 15 days of use, a leak was found inside the patient and the device was removed and replaced with a new device.The patient experienced no complications and is in good condition.On 2/28/22 further information was provided stating that the client uses sterile water to inflate the cuff, as soon as the balloon ceased to be tight, the customer noticed that the tube could slip out and the administered nutritional formula was leaking.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
As reported by the customer: the device had to be replaced due to a leak in the balloon which was possibly due to a rupture.Additional information provided on 2/25/2022 stated that after 15 days of use, a leak was found inside the patient and the device was removed and replaced with a new device.The patient experienced no complications and is in good condition.On 2/28/2022 further information was provided stating that the client uses sterile water to inflate the cuff, as soon as the balloon ceased to be tight, the customer noticed that the tube could slip out and the administered nutritional formula was leaking.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One decontaminated nutriport balloon 14fr x 1.2cm.Without the original packaging identified as lot 2109720164 was received for evaluation.A visual inspection according to procedure, and a functional test was performed according to product specification concluded that when the balloon was filled with sterilized water, a leak was observed under the balloon.The root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 14 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: 13619558
• Report Number: 9612030-2022-03183
• Device Sequence Number: 11854307
• Product Code: KNT
• UDI-Device Identifier: 10884521010635
• UDI-Public: 10884521010635
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 05/05/2022

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: 714120
• Device Catalogue Number: 714120
• Device Lot Number: 2109720164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown