MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC STANDARD BALLOON REPLACEMENT KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00582150

Device Problem Fitting Problem (2183)

Patient Problem Discomfort (2330)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

I have had issues with boston scientific replacement gastrostomy tubes for more that several patients.After replacing the gastrostomy tube, it is noted that it does not accept a cath tip syringe or feeding administration set end well- it seems to repel the end.Had to change the patient's feeding tube because this occurred, have had other similar events.I have notified the company, sent tubes back to them.It is an inconvenience to patients at the least and an added expense not to mention increased time for the patient and health care worker; not related to any particular patient or condition.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC STANDARD BALLOON REPLACEMENT KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10282806
• MDR Text Key: 199315755
• Report Number: MW5095548
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2020

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 Operator: Health Professional
• Device Expiration Date: 03/22/2022
• Device Model Number: M00582150
• Device Lot Number: 01018203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR