MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-05-15 for ESTEEM STRETCHY NITRILE II LIGHT BLUE S 8811NB manufactured by Cardinal Health Malaysia 211 Sdn.bhd.
[75182670]
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.
Patient Sequence No: 1, Text Type: N, H10
[75182671]
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.
Patient Sequence No: 1, Text Type: D, B5
[87063188]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2017-00094 |
| MDR Report Key | 6567606 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-05-15 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-04-14 |
| Date Facility Aware | 2017-04-14 |
| Date Mfgr Received | 2017-04-14 |
| Date Added to Maude | 2017-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer G1 | CARDINAL HEALTH MALAYSIA 211 SDN.BHD |
| Manufacturer Street | ZONE PHASE IV, MK 12 LINTANG , |
| Manufacturer City | BAYAN LEPAS 11900 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 11900 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM STRETCHY NITRILE II LIGHT BLUE S |
| Generic Name | PATIENT EXAMINATION GLOVE |
| Product Code | FMC |
| Date Received | 2017-05-15 |
| Model Number | 8811NB |
| Catalog Number | 8811NB |
| Lot Number | 2M14E013 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH MALAYSIA 211 SDN.BHD |
| Manufacturer Address | ZONE PHASE IV, MK 12 LINTANG , BAYAN LEPAS 11900 MY 11900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-15 |