MAUDE Adverse Event Report: ANSELL N.P. SDN. BHD. ENCORE; SURGEON'S GLOVE

Catalog Number 10070

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/28/2016

Event Type  Injury  

Event Description

On (b)(6) 2016 surgeon complaint of glove tip ribbing off the glove tip fell in contact with patient wound.

Manufacturer Narrative

On 01/13/2017: customer logged complaint to plant for investigation.Glove fingertips defective with lumpy coating, coating peel off, weakness/weak hole and variation thickness.From the investigations, weakness/weak hole defect could be due to fin break in coagulant tank or in latex dip tank during the dipping process.Based on lot record, the product was produced between 3/21 and 3/24 2016.Weakness/weak hole - long fin break is due to high surface tension of coagulant or latex resulted in weakness or thin area in the crotch of the glove where the surface tension of the solution will create a film or web between the finger; particularly between the index and thumb fingers.If the web breaks, a bubble will form in this area and create a weak hole when the glove is formed.Corrective action taken by the manufacturing team such as increase the coagulent viscosity and move the coagulent dip from tank 1 to tank 3 to provide consistent coagulent thickness before reaching the coagulent over.This action was taken in (b)(6) 2016.Lumpy coating/coating peel off - there is an incident of surge in coating dip tank temperature to 30 c (range is 18-25); this occured during the production time of the lot in question.When the temperature high in coating dip tank results in coating becoming lumpy which in which the lumps would appear in the dipping process.The team stopped the line immediately and refreshed the dip tank.To mitigate the issue, a larger capacity chiller was installed(b)(6) 2016.Variation in thickness - cuff thickness shows no significant difference from jan 2016 to nov 2016.However, there was a reduction of palm and finger thickness (within range) since aug 2016 from the installation of in line chain component but the thickness range was still within specification.There have been no additional complaints of a similar nature reported at this time and the record was closed until further complaints/data become available.

Event Description

On 12/2/2016 surgeon complaint of glove tip ribbing off the glove tip fell in contact with patient wound.

• Brand Name: ENCORE
• Type of Device: SURGEON'S GLOVE
• Manufacturer (Section D): ANSELL N.P. SDN. BHD.; lot 80, air keroh ind. estate; melaka, melaka 75450 ; MY 75450
• MDR Report Key: 6140678
• MDR Text Key: 61300345
• Report Number: 1019632-2016-00012
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2016,01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 10070
• Device Lot Number: 1603452104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2016
• Distributor Facility Aware Date: 11/28/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR