3 CC LUERLOCK WITH 23G NEEDLE ATTACHED N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-02-25 for 3 CC LUERLOCK WITH 23G NEEDLE ATTACHED N/A manufactured by Monoject.

Event Text Entries

[15252304] A 30g cannula from visitec was attachedd to the syringe. While using it to irrigate the eye, the cannula detached, causing a tear in the posterior capsule. The lens implant became dislodged, floating to the back of the eye. An anterior vitrectomy was then performed and an anterior lens inserted. On 2/3/92, the doctor stated the patient's vision was clearingdevice labeled for single use. 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, other, other, invalid data. Results of evaluation: none or unknown, invalid data, invalid data, invalid data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 75
• MDR Report Key: 75
• Date Received: 1992-02-25
• Date of Report: 1992-02-07
• Date of Event: 1992-01-27
• Date Facility Aware: 1992-01-27
• Report Date: 1992-02-07
• Date Reported to FDA: 1992-02-07
• Date Reported to Mfgr: 1992-02-04
• Date Added to Maude: 1992-03-25
• 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: 3 CC LUERLOCK WITH 23G NEEDLE ATTACHED
• Generic Name: N/A
• Product Code: EIB
• Date Received: 1992-02-25
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: UNKNOWN
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 73
• Manufacturer: MONOJECT

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-02-25