MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC BULB SYRINGE IN CUSTOM HAND SURGICAL PACK; GENERAL SURGERY TRAY (KIT)

Lot Number 345273

Device Problem Moisture Damage (1405)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/08/2020

Event Type  malfunction  

Event Description

Operating room staff setting up for humeral fracture surgery, upon setup noted sterile bulb syringe that comes in the cardinal hand pack has visible moisture droplets present in the clear plastic part.Rn in room removed the green bulb from the syringe and stated that he physically touched the moisture inside of the sterile syringe.Operating room team broke down entire surgical set up and opened new supplies and implants.The cardinal health hand pack lot number 345273 removed from or shelf.I am in process of contacting supply chain to remove from storeroom.

• Brand Name: BULB SYRINGE IN CUSTOM HAND SURGICAL PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 10082414
• MDR Text Key: 191812702
• Report Number: 10082414
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 345273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1