MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. 8"(20CM)PRESS.INF.(400PSIG)EXT SET W/REM. MC; IV EXTENSION SET

Model Number	Z3030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2014
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint rec'd regarding an unknown qty.Of z3030, 8" (20 cm) pressure infusion (400psig) ext set w/remv microclave, clamp, rotating luer, non-dehp tubing lot# 34-589-he (mfg.Date 11/2013).The initial report states,"defective option-lok".There was no patient involvement.
Additional Manufacturer Narrative
Lot analysis: a review of the mfg.Lot database for the following lots: lot# 34-589-he (mfg.Date 11/2013) (b)(4) units, lot# 35-496-jw (mfg.Date 11/2013) (b)(4) units, lot# 36-380-sl (mfg.Date 12/2013) (b)(4) units, lot# 33-980-sl (mfg.Date 10/2013) (b)(4) units, lot# 35-600-sj (mfg.Date 12/2013) (b)(4) units, lot# 35-054-jw (mfg.Date 11/2013) (b)(4) units, shows all units were manufactured, tested, inspected, and released.There was no exception documentation generated during the manufacturing lot build.Mfg analysis and investigation: mfg.Rec'd fifteen (15) opened/unused z3030 from all above lots and no visble anomolies were recorded.No mating devices were returned.Functional and performance testing on returned z3030 devices showed that the spin collar retention (stiction) to the male luer (checked after rotating and pushing the spin collar back and then removing the cover) was high on 11/15 devices.Five (5) of the devices were attached to in house 20g smiths medical jelco iv catheters using a torque value of 1.0 in lbs per the specification requirement and simulating usage.The devices were then leak tested with water at 400 psig (a total of 3 times).No leaks were found and the connections between the spin collars and iv catheters did not separate.The devices were tested per internal product performance specification.The reported product problem could not be confirmed, and the exact cause of the problem remains unknown.Icu medical identified technique related variables that could contribute to user issues, and guidance was communicated to the customer.Further enhancements to the relevant products and processes were identified.The team reviewed applicable design, materials, and manufacturing and equipment processing parameters.

• Brand Name: 8"(20CM)PRESS.INF.(400PSIG)EXT SET W/REM. MC
• Common Device Name: IV EXTENSION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia, costa rica ; CS
• Manufacturer (Section G): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa., 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 4455 atherton dr; salt lake city, UT 84123 ; 2247062300
• MDR Report Key: 19711655
• Report Number: 2025816-2014-00169
• Device Sequence Number: 15588798
• Product Code: FPA
• UDI-Device Identifier: 00887709029156
• UDI-Public: (01)00887709029156(17)181101(10)34-589-HE
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: Z3030
• Device Catalogue Number: Z3030
• Device Lot Number: 34-589-HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BD NEEDLE.
• Patient Sex: Unknown