MAUDE Adverse Event Report: ICU MEDICAL, INC. 5" BAG SPIKE ADAPTOR W/ SPIROS

Model Number 20123-01

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894); Connection Problem (2900)

Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

Complaint received reporting leakage incident with use of 20123-01 5" bag spike adaptor w/ spiros, vented cap and unk hosp pump tubing set.The info received reports vp-16 tubing leaked at connector (site) ".As rn connected the flush bag to the tubing.Remaining vp-16 (<5 cc) caught by rn with gloves.Chemo fell down gown sleeve onto rn's skin and long sleeve shirt.Blood began to return through tubing still connected - rn clamping tubing, disconnected it, and flushed line.Rn washed site (l forearm) thoroughly." following chemo exposure treatment protocol, clinician reportedly experienced no adverse consequences.Device return: one (1) used 20123-01 5" bag spike adapter w/ spiros, attached to an unk ext.Set.Visual inspection (pre and post decontamination) was performed.The report noted that during decontamination flushing, leakage was seen originating from the male end of the 20123-01 device sets spiros connector.Upon closer inspection damages were seen on the body of the spiros connector.

Manufacturer Narrative

Engineering evaluations: the returned 20123-01 5" bag spike adaptor w/ spiros was pressure leak tested at 10 psi.The results recorded the sets spiros connector leaked through a crack at the male luer end.Further analysis identified a radial crack that extended around the full circumference of the spiros body just below the blue strap at the male luer end.The characteristics of the crack/damage were brittle in nature and typical of environmental stress cracking.Although not always repeatable previous engineering investigations of these types of material damages/stress cracks have been replicated.Those investigations found that when the plastic componentry is weakened by chemical exposures and then subjected to various axial and/or torque force it can potentially result in these types of cracks/damages.Findings: the reported 20123-01 leakage issue was confirmed.The engineering eval identified the source of the leakage was due to damages/radial cracks on the housing of the spiros connector.The engineering report documents the most likely case to be a combination of chemical exposures and usage/techniques that employed axial/bending torque forces.

• Brand Name: 5" BAG SPIKE ADAPTOR W/ SPIROS
• Type of Device: 5" BAG SPIKE ADAPTOR W/ SPIROS
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton dr; salt lake city, UT 94123 ; 8012641400
• MDR Report Key: 4407226
• MDR Text Key: 5306207
• Report Number: 2025816-2014-00111
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20123-01
• Device Catalogue Number: 20123-01
• Other Device ID Number: PR# 26915
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/11/2014
• Event Location: Hospital
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SYRINGE - NOI; UNK PUMP TUBING SET