MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 20 FR X 1.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 720170

Device Problem Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2021

Event Type  malfunction  

Event Description

The customer stated the patient had a button placed on (b)(6) 2021.While at home, the patient's peg button had a balloon failure and leaked following a tussive episode with vomiting.They went to the er where the new kangaroo 12fr was repositioned.It was filled with 2.5ml, reflux of gastric material occurred and the probe was functioning.The customer clarified there was no additional surgery, the device was replaced in the er.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Evaluation summary.The device history record (dhr) review could not be performed because the reported lot number is not a valid lot number.One decontaminated nutriport without its original package or lot number was received at the manufacturing plant for evaluation.It was visually inspected according to procedure.The balloon was filled with sterile water, and a leak was observed under the balloon.The reported condition was confirmed.A corrective and preventative action (capa) was opened to determine the root cause and corrective actions.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

D4 lot number corrected & nbsp; from lot 20022114564 to lot 2107429764 per information received from the customer.

• Brand Name: BALLOON SLG 20 FR X 1.7 CM
• Type of Device: 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: 13440800
• MDR Text Key: 284974254
• Report Number: 9612030-2022-03150
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521011267
• UDI-Public: 10884521011267
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

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: 720170
• Device Catalogue Number: 720170
• Device Lot Number: 2107429764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 01/27/2022; 01/27/2022
• Supplement Dates FDA Received: 04/11/2022; 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1