MAUDE Adverse Event Report: ICU MEDICAL, INC. 3-WAY STOPCOCK W/BONDED MICROCLAVE

Model Number 011-C3352

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

Lot review of suspect lots: suspect lot 2762438 cited no exception documents.Suspect lot 2747997 cited no exception documents.Suspect lot 2764366 cited no exception documents.

Event Description

Complaint received regarding three 011-c3352, 3-way stopcock w/bonded microclave®, rotating luer; hospital in (b)(6), no lot number.Report states: during the infusion the device had leakage.The 3cc blood loss and delay in critical therapy reported, did not receive all propofol.No serious adverse consequences reported.

Manufacturer Narrative

Lot review of suspect lots: suspect lot 2762438 cited no exception documents.Suspect lot 2747997 cited no exception documents.Suspect lot 2764366 cited no exception documents.Visual investigation: received: two used 011-c3352, 3-way stopcock w/bonded microclave®, rotating luer, reported lot# 2762438.Three used 011-c3352, 3-way stopcock w/bonded microclave®, rotating luer; reported lot# 2747997.No mating devices were returned.Each of the 3 units listed in bag with lot # 2747997 were visually inspected.All three of the units were observed to have a cracked female luer on the stop cock.Crazing of the female luer was also observed.Functional testing: each of the three units were leak tested.Activated and inactivated pressure leak testing, along with section 5.0 vacuum leak testing.No leaking of the microclave or the stop cock was observed except where the female luer of the stopcock was cracked.The cracked female luer is consistent with environmental stress.The observed failure was observed to not have been caused from manufacturing processes.Final analysis summary: the reported complaint of leaking was confirmed.For the three units retuned in lot 2747997 the female luer of the stopcock was observed to have been damaged from environmental stress.For the two units from lot 2762438 both of the microclaves were observed damaged from an incompatible mating device.Icu medical will continue to monitor and trend.

Event Description

Complaint received regarding three 011-c3352, 3-way stopcock w/bonded microclave®, rotating luer; hospital in (b)(6), no lot number.Report states: during the infusion the device had leakage.3cc blood loss and delay in critical therapy reported, did not receive all propofol.No serious adverse consequences reported.

• Brand Name: 3-WAY STOPCOCK W/BONDED MICROCLAVE
• Type of Device: 3-WAY STOPCOCK W/BONDED MICROCLAVE
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 6159002
• MDR Text Key: 62241359
• Report Number: 2025816-2016-00275
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 011-C3352
• Device Catalogue Number: 011-C3352
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1