MCGAW N/A N2044

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-15 for MCGAW N/A N2044 manufactured by Mcgaw.

Event Text Entries

[1113] The patient called to say that he noticed fluid leaking from the end of his groshong catheter. He twisted the cap to see if it was secure and the top of the cap broke off. The luer lock portion of broken cap remained in the groshong and could not be removed. The patient had to go to a hospital er to replace the end of his groshong catheter. Invalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: other. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1353
MDR Report Key1353
Date Received1992-09-15
Date of Report1992-09-01
Date of Event1992-08-26
Date Facility Aware1992-08-26
Report Date1992-09-01
Date Reported to FDA1992-09-01
Date Reported to Mfgr1992-09-01
Date Added to Maude1992-09-23
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMCGAW
Generic NameLUER LOCK CAP
Product CodeFFR
Date Received1992-09-15
Model NumberN/A
Catalog NumberN2044
Lot NumberF20740 F20271
ID NumberN/A
OperatorOTHER CAREGIVERS
Device AvailabilityY
Implant Flag*
Device Sequence No1
Device Event Key1297
ManufacturerMCGAW


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-09-15

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