MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CONVERTORS; GOWN, SURGICAL

Model Number 9515

Device Problems Material Puncture/Hole (1504); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2019

Event Type  malfunction  

Event Description

Three issues with surgical gowns:(1) surgical gown was opened for surgeon to don and he noticed a hole in the mid section of the gown.(2) surgical gown ties are torn (torn from inside and the inside tie broke off).(3) surgical gown is coming apart near the wrist (has a hole in the seam).Two gowns are ref: (b)(4) and lot: 18lwq004; one gown is ref: (b)(4) and lot: 18kbj029.

• Brand Name: CONVERTORS
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8669752
• MDR Text Key: 147027836
• Report Number: 8669752
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380153563
• UDI-Public: (01)10885380153563(17)231107(10)18LWQ004
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9515
• Device Catalogue Number: 9515
• Device Lot Number: 18LWQ004
• 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: 05/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1