CARDINAL HEALTH-FLEXAM 64-8660

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5069440
MDR Report Key6533429
Date Received2017-04-27
Date of Report2017-04-27
Date of Event2017-04-23
Date Added to Maude2017-05-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameCARDINAL HEALTH-FLEXAM
Generic NameSTERILE GLOVES
Product CodeLYY
Date Received2017-04-27
Model Number64-8660
Lot Number4S16D003
Device Expiration Date2019-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH

Device Sequence Number: 2

Brand NameCARDINAL HEALTH-FLEXAM
Generic NameSTERILE GLOVES
Product CodeLYY
Date Received2017-04-27
Model Number64-8660
Lot Number9L16E002
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerCARDINAL HEALTH


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.