MAUDE Adverse Event Report: AVID MEDICAL, INC. MAJOR PACK; BASIN, PACK KIT

Lot Number 1303785

Device Problems Material Puncture/Hole (1504); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2018

Event Type  malfunction  

Event Description

When the major pack was opened, a large hole was found in the basin that is wrapped in the major pack.

• Brand Name: MAJOR PACK
• Type of Device: BASIN, PACK KIT
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont dr.; stonehouse commerce park; toano VA 23168
• MDR Report Key: 7854769
• MDR Text Key: 119499902
• Report Number: 7854769
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2018

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: No Information
• Device Lot Number: 1303785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1