MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ANGIO PACK; GENERAL SURGERY TRAY

Model Number DYNJ37706

Device Problems Bent (1059); Sticking (1597)

Patient Problem No Information (3190)

Event Date 08/06/2015

Event Type  malfunction  

Event Description

Access needle housing bent w/needle picking through.The 10cc syringes have sticky plungers - hard to slide.

• Brand Name: ANGIO PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein, IL 60060
• MDR Report Key: 5196972
• MDR Text Key: 30215086
• Report Number: 5196972
• Device Sequence Number: 1
• Product Code: LRO
• 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: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: DYNJ37706
• Device Catalogue Number: DYNJ37706
• Device Lot Number: 15EB8034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2015
• Type of Device Usage: N
• Patient Sequence Number: 1