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

Catalog Number	2D73PM65
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The customer had the sample but the manufacturing facility did not need it to be returned due to their identification of the problem.It appears that a new alternate source of polyisoprene had less tear resistance than a previous source for the same thickness control.We have resumed sourcing product from the previous supplier.
Event or Problem Description
Physician complained of multiple glove tears during a laparoscopic tah bso - one glove tore in multiple pieces.Some pieces were retrieved from the abdomen and some were found on the floor of the or.The surgeon did order additional antibiotics.No additional updates available on the patient.

• Brand Name: GLOVE SURGICAL PROTEXIS PI MICRO
• 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
• MDR Report Key: 8420674
• Report Number: 1423537-2019-00287
• Device Sequence Number: 2170449
• Product Code: KGO
• UDI-Device Identifier: 10885380027277
• UDI-Public: 10885380027277
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 2D73PM65
• Device Lot Number: TS18090309
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 103