FLEXAL 88TNF04L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for FLEXAL 88TNF04L manufactured by Cardinal Health 200, Llc.

Event Text Entries

[137510212] Gloves are ripping in the fingertips and cuffs. Absolutely not safe for chemotherapy administration or isolation rooms. Both boxes were by cardinal heath, the nitrile exam gloves (flexal) the first box had a lot # of 11a18l013 with a "ref" number at the top of the box (b)(4). The second box had a lot # of 11s18k508. Manufacturer response for nitrile exam gloves, (brand not provided) (per site reporter). Thank you for these additional details, having these lot #s will allow me to file a product quality report internally and we can then understand if this is an isolated issue or a more widespread occurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8381402
MDR Report Key8381402
Date Received2019-03-01
Date of Report2019-02-28
Date of Event2019-02-24
Report Date2019-02-28
Date Reported to FDA2019-02-28
Date Reported to Mfgr2019-03-01
Date Added to Maude2019-03-01
Event Key0
Report Source CodeUser Facility 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 Report3

Device Details

Brand NameFLEXAL
Generic NamePOLYMER PATIENT EXAMINATION GLOVE
Product CodeLZA
Date Received2019-03-01
Model Number88TNF04L
Catalog Number88TNF04L
Lot Number11A18L013
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-01

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