MAUDE Adverse Event Report: C.R.BARD, INC. DIGNISHIELD STOOP MANAGAMENT SYSTEM; TUBE, GASTROINTESTINAL

Catalog Number SMS002

Device Problems Device Inoperable (1663); Component Missing (2306); Structural Problem (2506)

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

Event Date 11/22/2016

Event Type  malfunction  

Event Description

The port on tube was missing a piece that keeps the port closed.With piece missing there is no way to close port and this makes the tube unable to use.

• Brand Name: DIGNISHIELD STOOP MANAGAMENT SYSTEM
• Type of Device: TUBE, GASTROINTESTINAL
• Manufacturer (Section D): C.R.BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 6198136
• MDR Text Key: 63086009
• Report Number: 6198136
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: SMS002
• Device Lot Number: NGAR1030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO