MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-27 for CARDINAL HEALTH-FLEXAM 64-8660 manufactured by Cardinal Health.
[74165472]
Picc nurse donned on sterile gown for the procedure and as he proceeded to open the sterile glove, he noted there was only one glove in the packet and a hole on the glove tip for the pinkie. The picc nurse opened 3 packets, 2 out of 3 had a hole. The employee reported the defected product and did not save the product package. There are 2 different lot numbers for the same product, by the same company. Lot #4s16d003 and lot # 9l16e002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069440 |
| MDR Report Key | 6533429 |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-04-23 |
| Date Added to Maude | 2017-05-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARDINAL HEALTH-FLEXAM |
| Generic Name | STERILE GLOVES |
| Product Code | LYY |
| Date Received | 2017-04-27 |
| Model Number | 64-8660 |
| Lot Number | 4S16D003 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Brand Name | CARDINAL HEALTH-FLEXAM |
| Generic Name | STERILE GLOVES |
| Product Code | LYY |
| Date Received | 2017-04-27 |
| Model Number | 64-8660 |
| Lot Number | 9L16E002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-27 |