MAUDE Adverse Event Report: CARDINAL HEALTH MALAYSIA 211 SDN.BHD ESTEEM STRETCHY NITRILE II LIGHT BLUE S; PATIENT EXAMINATION GLOVE

Model Number	8811NB
Health Effect - Clinical Code	Reaction (2414)
Date of Event	04/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Historical trending for the past 12 months: this is the 1st complaint for this glove type and failure mode.The device history record was reviewed and no abnormality noted.All manufacturing process control and operating parameters were within the validated specification and no abnormality was found.No change was made to the raw materials and suppliers, compounding formulation, or manufacturing process during the production of this lot.Pre-shipment testing and quality inspection of this lot passed all testing and inspection requirements prior to final shipment release.Inspection and testing of gloves from this lot at the time of release prior to shipment met all requirements as specified for this product.A root cause could not be identified without the issue samples.It is to be noted that sensitivity of individuals to nitrile gloves may be a factor in developing allergic reaction or skin irritation from wearing such gloves.Manufacturing process was reviewed by the glove manufacturer to ensure it is running with the validated parameters and within normal process capability.  the glove manufacturer will continue to ensure that the manufacturing process is stable as well as capable, good manufacturing practices are adhered to and continuous improvement strategies are implemented in order to ensure gloves are consistently produced according to the required specification prior to packing and release for shipment.
Event or Problem Description
Based on information received from the customer, an employee possibly had an allergic reaction to our nitrile gloves.The employee was seen by the doctor.  no further information could be obtained from the customer.
Additional Manufacturer Narrative
The returned glove complaint samples were received for evaluation and tested, but did not exhibit any visible abnormality.Further testing of the glove samples showed the glove ph was close to the neutral range and the extractable chemical residue test results showed ¿not detected¿ or the concentration is below the detectable limit for the identified chemicals on the gloves that could potentially cause allergic reaction to users. based on the results for the samples received we are unable to determine the root cause at this time.  no corrective action will be taken based on the investigation results, but we will continue to monitor for trends.

• Brand Name: ESTEEM STRETCHY NITRILE II LIGHT BLUE S
• Common Device Name: PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): CARDINAL HEALTH MALAYSIA 211 SDN.BHD; zone phase iv, mk 12 lintang ,; bayan lepas 11900 ; MY 11900
• MDR Report Key: 6567606
• Report Number: 1423537-2017-00094
• Device Sequence Number: 10994436
• Product Code: FMC
• UDI-Device Identifier: 10885380134838
• UDI-Public: 10885380134838
• 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,user f
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2017

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: No Information
• Device Model Number: 8811NB
• Device Catalogue Number: 8811NB
• Device Lot Number: 2M14E013
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 06/14/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other