3611 LITE GLOVE 31140208

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-19 for 3611 LITE GLOVE 31140208 manufactured by Covidien.

Event Text Entries

[55336176] An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[55336177] It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports: product broken when trying to fit on the lamp handle. The second lite glove was found broken when removed from the box. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5


[68119356] Complaints have been received by medtronic stating the devon light glove splits/tears after application to the surgical light. The complaints involve lots manufactured may 2015 to current. Capa (b)(4) was opened january 2016 to address a small (. 0017%) population of complaints that were allegedly? Too tight?. The condition presented a challenge to the user as the glove was too tight during the installation onto the light handle, making the installation difficult to impossible, with the potential for tears. A multifunctional team reviewed the complaints and failure modes as part the capa investigation. An ishikawa diagram was completed focusing on the potential causes that could originate the reported conditions. The investigation determined that while the product met specification and the observed complaint rate was below the dmr requirements, process variation combined with the dimensional tolerance between the inner diameter of the glove and the corresponding handle could lead to application forces that split the light glove during application onto the associated light handle. The dimensional tolerance was related to a slight reduction of the inside diameter of the handle cover. This reduction in diameter was implemented, along with other factors, to eliminate pleats in the glove and minimize the potential for splits and tears. This resulted in a small number of light gloves that fit tightly and or split when applied to the light handle. In june 2016, the corrective action was implemented through process modifications that included updates to both equipment and inspection criteria whereby insertion force was now measured on the line. Additionally, a field safety notice communicating an update to the ifu was issued september 29, 2016 to further mitigate the risk of a too tight or split condition. In october 2016, post implementation of the above corrective actions, complaints were received reporting the product is split in the package, the product split/tore during application or a split was discovered during or post patient procedure. As such, capa (b)(4) was opened to document the investigation and actions taken. The initial investigation determined that while the product meets specification and the observed complaint rate is below the dmr requirements, additional testing and review is necessary to take corrective action to further reduce risk as far as possible. Ongoing efforts at this time include review of the material, process parameters, and design. Further investigation is necessary to determine root cause of this issue. In jan 2017 medtronic conducted a recall of its covidien devon? Light gloves distributed as single sterile items and in specific procedure kits. All lot numbers of devon? Light glove devices within expiry beginning with lot number 630xxxxxxx and lower are affected by this field action.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612030-2016-00438
MDR Report Key5959571
Date Received2016-09-19
Date of Report2016-09-06
Date of Event2016-09-01
Date Mfgr Received2017-02-22
Date Added to Maude2016-09-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL
Manufacturer CityTIJUANA
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3611 LITE GLOVE
Generic NameLITE GLOVE
Product CodeLYU
Date Received2016-09-19
Model Number31140208
Catalog Number31140208
Lot Number6145100064
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX


Patients

Patient NumberTreatmentOutcomeDate
10 2016-09-19

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