CLICK LOCK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for CLICK LOCK manufactured by Icu Medical, Inc..

Event Text Entries

[2982] The rubber injection port become dislodged from click lock cap during routine flushing. No blood loss. Click lock was clamped immediately. Accordingly to clinical engineering rubber stopper had seperated from the cap taking the plastic holding band with it. An unused cap was randonly pulled from stock. It pulled apart fairly easily. This is the second time one of these caps seperated while in use on the patientinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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, a device from same lot was evaluated, mechanical tests performed, visual examination. Results of evaluation: component failure, design - inadequate, manufacturing. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4788
• MDR Report Key: 4788
• Date Received: 1992-07-31
• Date of Report: 1992-02-27
• Date of Event: 1992-02-13
• Date Facility Aware: 1992-02-13
• Report Date: 1992-02-27
• Date Reported to Mfgr: 1992-02-27
• Date Added to Maude: 1993-06-07
• 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: CLICK LOCK
• Product Code: KQQ
• Date Received: 1992-07-31
• Lot Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4504
• Manufacturer: ICU MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-31