MAUDE Adverse Event Report: CARDINAL HEALTH, INC. VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7317

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Event Description

X-ray detectable sponges opened onto surgical field.Discovered 15 sponges in the box rather than the standard of practice 10 sponges / package.Deviation from practice standard could contribute to unintentional retention of foreign body.Per practice standard, sponges were passed off the surgical field and isolated.No patient harm.

• Brand Name: VISTEC
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 300 south riverside plaza; chicago IL 60606
• MDR Report Key: 9563814
• MDR Text Key: 174147952
• Report Number: 9563814
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: (01)10884527016990
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 19J050962
• 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: 12/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1