MAUDE Adverse Event Report: CARDINAL HEALTH (THAILAND) 222 LIMITED GLOVE SURGICAL PROTEXIS PI CLASSIC; SURGEON'S GLOVES

Model Number	2D72PL75X
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer stated a surgical glove breach occurred during c-section delivery.Surgeon was found to have a hole in her glove during procedure.The hole was noticed after the uterus and fascia were closed.Surgeon concerned that piece of glove could have been left inside the patient.As a precaution the surgeon opened the abdomen and uterus back up and performed an exploration and irrigation to see if she could find any piece of the glove.No piece of a glove was found.The patient was prescribed iv ancef while she was admitted to the hospital.
Additional Manufacturer Narrative
As no samples were returned for evaluation, a root cause could not be determined.A review of the physical properties trending found tensile strength and cuff, palm, and finger thickness were within specification.The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.Cardinal health will continue to monitor and trend all similar reported product related issues.

• Brand Name: GLOVE SURGICAL PROTEXIS PI CLASSIC
• Common Device Name: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer (Section G): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 17337353
• Report Number: 1423537-2023-00961
• Device Sequence Number: 15286624
• Product Code: KGO
• UDI-Device Identifier: 10885380031786
• UDI-Public: 10885380031786
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2D72PL75X
• Device Catalogue Number: 2D72PL75X
• Device Lot Number: TS22050249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 83 KG