MAUDE Adverse Event Report: OWEN'S & MINOR MEDICHOICE; HEMOSTAT

Device Problem Break (1069)

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

Event Date 01/22/2014

Event Type  malfunction  

Event Description

One side of the metal hemostat broke off when the nurse clamped it down on tubing while disconnecting tubing from the patient's nasogastric tube.The nurse reported that she did not use extra force using the device.
=
manufacturer response for metal hemostat, medichoice (per site reporter).
=
it was returned to the vendor representative.

• Brand Name: MEDICHOICE
• Type of Device: HEMOSTAT
• Manufacturer (Section D): OWEN'S & MINOR; 9120 lockwood blvd; mechanicsville, VA 23116
• MDR Report Key: 4173760
• MDR Text Key: 5103236
• Report Number: 4173760
• Device Sequence Number: 1
• Product Code: HRQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2014

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: Nurse
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NG TUBING