MAUDE Adverse Event Report: WELLSPECT HEALTCARE, A DIVISION OF DENTSPLY IH AB NAVINA CONSUMABLE SET; GASTROINTESTINAL TUBE AND ACCESORIES

Model Number 69003

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation of the returned device has not shown any explanation to why the balloon burst happened and there are no deviations for this batch.Several attempts have been made to receive more information from the patient but no response have been received.

Event Description

Balloon burst inside patient.No information about any medical complication received.Incident occured in (b)(6).

• Brand Name: NAVINA CONSUMABLE SET
• Type of Device: GASTROINTESTINAL TUBE AND ACCESORIES
• Manufacturer (Section D): WELLSPECT HEALTCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; mölndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE (A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o.box 14; mölndal, SE-43 121; SW SE-43121
• Manufacturer Contact: gabriella gärds ; aminogatan 1; p.o.box 14; mölndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 9762557
• MDR Text Key: 196777350
• Report Number: 3009632672-2020-00001
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 07392532198403
• UDI-Public: 07392532198403
• Combination Product (y/n): N
• PMA/PMN Number: K170487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2021
• Device Model Number: 69003
• Device Catalogue Number: 69003
• Device Lot Number: 439496
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1