MAUDE Adverse Event Report: CARDINAL HEALTH STERILE MAJOR BASIN; CUSTOM STERILE MAJOR BASIN PACK

Model Number SUT21MBARD

Device Problems Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Information (3190)

Event Date 05/15/2017

Event Type  malfunction  

Event Description

While removing a sterile major basin pack from the shipping carton, the operating room supply tech noticed the pack was soiled with a brown liquid.There appears to be a spot of mold growing in an area where pooling of the liquid occurred.With closer inspection, the shipping carton has dried streaks on the exterior.Manufacturer response for custom sterile major basin pack, cardinal (per site reporter): customer service has been alerted and they are processing a return.We will contact the sales rep this afternoon.

• Brand Name: STERILE MAJOR BASIN
• Type of Device: CUSTOM STERILE MAJOR BASIN PACK
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan rd.; waukegan IL 60085
• MDR Report Key: 6600701
• MDR Text Key: 76288249
• Report Number: 6600701
• 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: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2021
• Device Model Number: SUT21MBARD
• Device Catalogue Number: SUT21MBARD
• Device Lot Number: 691768
• 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: 05/17/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2017
• 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