MEDEX? CLEAR-CUFF PRESSURE INFUSOR MX4705

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-05-16 for MEDEX? CLEAR-CUFF PRESSURE INFUSOR MX4705 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[75312363] The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed. Device evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10


[75312364] It was reported that a medex? Clear-cuff pressure infusor had burrs and was leaking. No injury was reported. See mfr: 3012307300-2017-01012, 3012307300-2017-01077, 3012307300-2017-01078, 3012307300-2017-01079, 3012307300-2017-01080, 3012307300-2017-01081, 3012307300-2017-01082, 3012307300-2017-01083, 3012307300-2017-01084, and 3012307300-2017-01085, and 3012307300-2017-01086.
Patient Sequence No: 1, Text Type: D, B5


[86860553] Twelve devices were received for evaluation. Visual inspection of the devices discovered small burrs on the side of the bags. Functional testing involved a leak test and all twelve devices were inflated and left overnight; it was observed that the devices held the same amount of air that the devices were inflated with, and therefore the leaking was not observed. A review of the manufacturing process identified that dies that were used to cut the device were dull and needed adjustment, which was corrected prior to the production of the reported lot. Based on the evidence, the complaint was unable to be confirmed. The returned device functioned as specified. There was no evidence to indicate that there was an intrinsic defect in the product.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3012307300-2017-01087
MDR Report Key6569127
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2017-05-16
Date of Report2017-06-12
Date of Event2017-04-18
Date Mfgr Received2017-05-30
Device Manufacturer Date2016-11-15
Date Added to Maude2017-05-16
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 ContactJENNIFER MENG
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone7633833078
Manufacturer G1SMITHS MEDICAL ASD INC.
Manufacturer Street6250 SHIER RINGS ROAD
Manufacturer CityDUBLIN OH 43016
Manufacturer CountryUS
Manufacturer Postal Code43016
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDEX? CLEAR-CUFF PRESSURE INFUSOR
Generic NameINFUSOR, PRESSURE, FOR I.V. BAGS
Product CodeKZD
Date Received2017-05-16
Returned To Mfg2017-05-10
Catalog NumberMX4705
Lot Number3317569
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-16

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