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 Number: 1353
• MDR Report Key: 1353
• Date Received: 1992-09-15
• Date of Report: 1992-09-01
• Date of Event: 1992-08-26
• Date Facility Aware: 1992-08-26
• Report Date: 1992-09-01
• Date Reported to FDA: 1992-09-01
• Date Reported to Mfgr: 1992-09-01
• Date Added to Maude: 1992-09-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MCGAW
• Generic Name: LUER LOCK CAP
• Product Code: FFR
• Date Received: 1992-09-15
• Model Number: N/A
• Catalog Number: N2044
• Lot Number: F20740 F20271
• ID Number: N/A
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1297
• Manufacturer: MCGAW

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-09-15