MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-01-10 for GLV EXAM PF ESTEEM NEU-THERA NITRILE XS N88RX01T manufactured by Cardinal Health.
[3308754]
A phlebotomist had what appeared to be tiny glass fragments embedded in her hands. She saw her primary care provider on (b)(6) 2012. She did not immediately suspect the gloves. Her primary care provider suggested that the gloves could be the problem and to try an alternative. He recommended referral to dermatology if the problem was not able to be resolved by changing gloves. The phlebotomist changed to a new lot number which was okay. Her hands are better although there are still some scars. She did not feel it necessary to see dermatology at this point.
Patient Sequence No: 1, Text Type: D, B5
[10352986]
The lot number was provided, therefore the device history record was reviewed and no abnormalities were noted. Historical trending found this to be the first reported incident of this lot, catalog number, and failure mode. Samples were provided, and visual inspection of the returned samples found no abnormalities. Based on the complaint description and on the testing conducted of the returned samples, this appears to be an isolated incident. The root cause for the complaint could not be determined. The supplier has been apprised of this reported incident and will continue to monitor the manufacturing process including their management of the glove formers. We will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2013-00003 |
| MDR Report Key | 2906934 |
| Report Source | 05,08 |
| Date Received | 2013-01-10 |
| Date of Report | 2013-01-10 |
| Date of Event | 2012-11-27 |
| Date Mfgr Received | 2012-12-13 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2013-01-10 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLV EXAM PF ESTEEM NEU-THERA NITRILE XS |
| Generic Name | GLOVE, PATIENT EXAMINATION, SPECIALTY |
| Product Code | LZC |
| Date Received | 2013-01-10 |
| Returned To Mfg | 2012-12-24 |
| Catalog Number | N88RX01T |
| Lot Number | 5W11K001 |
| Device Expiration Date | 2014-07-31 |
| Operator | PHLEBOTOMIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-10 |