MAUDE Adverse Event Report: ICU MEDICAL INC 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (40; IV EXTENSION SET

Model Number	12514-01
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(continued from b.5) functional testing was performed with the returned device samples to the applicable product specification.The results recorded no connection issues, leakages or performance issues.Engineering testing and analysis recorded no functional issues and/or out of spec conditions.The exact cause of the product 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.
Event or Problem Description
Repeat complaint rec'd regarding an unknown qty.Of (b)(4), 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set; lot# 31-488-sl (mfg.Date 07/2013) and 31-495-sl (mfg.Date 07/2013).The report states, "the new extension set is much harder to seat into the iv jelco catheter, and many times requires a two handed technique.The increased manipulation is compromising the iv catheter, and if not seated properly will cause leaking around the connection." no adverse patient consequences reported.Lot analysis: a review of the mfg.Lot database for lot#s 31-488-sl (mfg.Date 07/2013), and lot# 31-495-sl (mfg.Date 07/2013) shows each lot of (b)(4) units was manufactured, tested, inspected, and released.There was no exception documentation generated during any of the mfg.Lot builds.Mfg investigation/analysis: mfg rec'd five (5) new/ unused 12514-01, ext sets; lot# 31-488-sl (2), 30-574-sj (1) and 31-495-sl (2).Also rec'd six (6) new/unused smith medical jelco 20 (3) and 22 (3) gauge protect iv plus safety catheters that were visually inspected with no anomalies present.All devices met required iso standard specifications for luer tapers, iso 594-1.

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (40
• Common Device Name: IV EXTENSION SET
• Manufacturer (Section D): ICU MEDICAL INC; 600 n. field dr; lake forest IL 60045
• 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
• MDR Report Key: 19554768
• Report Number: 2025816-2014-00168
• Device Sequence Number: 6806353
• Product Code: FPA
• UDI-Device Identifier: 00887709044470
• UDI-Public: (01)00887709044470(17)180701(10)31-488-SL
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/22/2014

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: 07/01/2018
• Device Model Number: 12514-01
• Device Catalogue Number: 12514-01
• Device Lot Number: 31-488-SL,31-495-SL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2014
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2012
• 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: (CONT) IV PLUS SAFETY CATHETER; SMITH MEDICAL JELCO 20 (3) AND 22 (3) GAUGE PROTEC
• Patient Sex: Unknown