MAUDE Adverse Event Report: CARDINAL HEALTH MALAYSIA 211 SDN.BHD GLV EXAM NITRILE ESTEEM MOIST PF SM; PATIENT EXAMINATION GLOVE, SPECIALTY

Model Number N88RX02T

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

Two lot numbers were provided by the customer.A device history record review was conducted on lot numbers 5w18l012 and 5w18s001.No exception was recorded in the device history records that could lead to the reported incident.Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.Manufacturing checked the raw material supply, the formulation, the production process and the retained samples, no abnormality was found.The raw materials are coming from the qualified suppliers and it is tested by the lab before use.In the compounding process, the raw materials are mixed by formulation and the parameters are controlled within level and no abnormal situation occurred.One box of samples were returned for lot number 5w18s001.Samples have been forwarded on for skin irritation testing.Manufacturing reviewed irritation test reports conducted in 2010, the test results show that there is not a primary dermal irritant.At this time the root cause could not be determined.Manufacturing will intensify the inspection of the parameters during production, to ensure they are within the standard, and increase the donning test.

Event Description

Based on information received from the customer, the lab tech reportedly had a skin reaction to the glove.They sought medical treatment, however the treatment they received is unknown.Two lot numbers were provided by the customer; however, they are unsure as to the lot number that may have caused the skin irritation.The lab tech is now using a cloth liner under the glove.

Manufacturer Narrative

The sample evaluation is still underway.No further results available at this time.

Manufacturer Narrative

One box of samples was returned for investigation.We sent 10 pieces of glove samples to a 3rd party lab to conduct the primary skin irritation testing.The results showed that no abnormal signs were observed.From the investigation, the root cause could not be determined.At this time no corrective action will be taken.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.

• Brand Name: GLV EXAM NITRILE ESTEEM MOIST PF SM
• Type of Device: PATIENT EXAMINATION GLOVE, SPECIALTY
• Manufacturer (Section D): CARDINAL HEALTH MALAYSIA 211 SDN.BHD; zone phase iv, mk 12 lintang ,; bayan lepas 11900 ; MY 11900
• MDR Report Key: 8508720
• MDR Text Key: 141750648
• Report Number: 1423537-2019-00306
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N88RX02T
• Device Catalogue Number: N88RX02T
• Device Lot Number: 5W18S001
• Date Manufacturer Received: 03/20/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other