MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-10-04 for GLV EXAM ESTEEM SYN PF(VYL) LG 8883 manufactured by Cardinal Health.
[10237422]
The device history record of the reported lot number was reviewed, and no abnormalities were noted. Historical trending was done. One box of gloves was received as the sample, and the water test was done. No abnormalities were found on the returned gloves. We are unable to identify the potential root cause. Since the reported complaint of blood contamination implies that a hole may have developed during or after use, the probable cause of the hole may be due to a dirty or worn off former. The manufacturer has been apprised of this complaint for close monitoring of the manufacturing process. The manufacturing team has taken action by cleaning the formers and removing worn off formers. We will continue to monitor complaints for any trends.
Patient Sequence No: 1, Text Type: N, H10
[20393421]
(b)(6) is filing this initial medwatch as the importer. The complaint was forwarded to the plant for investigation. The actual sample is not available, however the customer states that they can provide representative samples. Once the representative samples are received, they will be forwarded to the plant for investigation. When their investigation is completed, a follow up medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[20418067]
Nurse got a patient's blood on her glove. When she removed the glove, the blood was on her hand. The patient was diagnosed with a bloodborne infectious disease prior to this hospitalization. Nurse sought medical treatment. A physician inspected her hand for any cuts/scratches/open wounds (there were none). Baseline labs were drawn, and she will have 3 month and 6 month testing. She is doing fine now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2012-00038 |
| MDR Report Key | 2772651 |
| Report Source | 05,07 |
| Date Received | 2012-10-04 |
| Date of Report | 2012-10-22 |
| Date of Event | 2012-09-11 |
| Date Facility Aware | 2012-09-22 |
| Date Mfgr Received | 2012-09-22 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2012-10-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLV EXAM ESTEEM SYN PF(VYL) LG |
| Generic Name | GLOVE, PATIENT EXAMINATION, VINYL |
| Product Code | LYZ |
| Date Received | 2012-10-04 |
| Catalog Number | 8883 |
| Lot Number | 1P09N052 |
| Device Expiration Date | 2012-09-30 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-10-04 |