MAUDE Adverse Event Report: ICU MEDICAL, INC. SPIROS CONNECTOR

Model Number 20120-01

Device Problem Syringe, defective (1612)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 04/16/2014

Event Type  malfunction  

Event Description

Complaint received reporting a (b)(6) 2014 incident involving 20120-01 spiros connector and unknown syringe.It was reported that the "spiros snapped off of syringe when infusing drug into the bag.Pharmacy technician was sprayed with drug scrubs were cut off and the technician was sent directly to the ed".The technician was treated per hospital protocols and did not sustain any serious injuries or adverse outcomes.Device return: one (1) used 20120-01 spiros connector, one (1) used 30" 20 drop admin set attached to a 100ml hospira saline bag; four (4) used 30ml bd syringes; three (3) used 20ml bd syringes.Visual inspection and analysis (pre and post decontamination) was performed.The results recorded no obvious abnormalities with the returned syringes.The visual inspection of the returned used set up recorded a male luer from a luer lock syringe was broken off inside the female luer of the spiros that was connected to the admin set.Dimensional analysis performed on the seven bd syringes recorded the male luer taper met the iso specifications and were compatible.

Manufacturer Narrative

The engineering analysis of the luer lock syringe male luer records the brittle characteristics of the breakage suggests that the male luer was weakened most likely due to exposure to chemotherapy drug prior to the breakage.Add'l.Engineering efforts to recreate the male luer breakage with one of the 20ml syringes was performed.A female luer was attached to the end of the bd 20ml syringe and a bending for ce was applied one inch away.It required 19.05 in-1bs of bending torque to separate the male luer from the female luer.The report documents that the separation was ductile where the male luer and thread skirt were bent rather than broken and did not exhibit "brittle" characteristics as seen with the returned devices.Findings: engineering analysis of the "as-received" devices confirmed component breakage of a luer lock syringe male luer inside the female luer of the spiros connector.The engineering analysis of the component breakage characteristics (brittleness) suggests that the mating syringe male luer was chemically weakened prior to the breakage.This condition combined with unintended bending forces most likely contributed to the breakage/damage and resultant leakage that occurred.The complaint investigation report, relevant photographs were provided to the reporting facility for their review, understanding and records.

• Brand Name: SPIROS CONNECTOR
• Type of Device: CONNECTOR
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 3881750
• MDR Text Key: 19925243
• Report Number: 2025816-2014-00062
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20120-01
• Device Catalogue Number: 20120-01
• Other Device ID Number: PR# 25047
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BD SYRINGE