MAUDE Adverse Event Report: ICU MEDICAL INC 7" NON-DEHP EXT. SET, MICROCLAVE CONNECTOR; IV EXTENSION SET

Model Number	12738
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2014
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint rec'd regarding connection issues with an unknown qty of (b)(4) - 7" non-dehp ext.Set, microclave connector, lot# unknown.The report states, ".Extension set will not stay screwed with iv catheter.There was patient involvement, but no adverse event, no delay in critical therapy, no blood loss and no bleed back." mfg investigation & analysis: received four (4) used 12738 ext.Sets.Mating accessory devices were not returned for testing and analysis.No obvious abnormalities were observed, and dimensional analysis showed the four male luers on the devices met the iso standard.Each of the devices' spin collar components were torqued onto in house iv catheters and (cont'd h.10).
Additional Manufacturer Narrative
(cont'd from b.5) leak tested.The results recorded no attachment/ connection, leakages or functional out of spec conditions per internal testing specifications.The exact cause(s) of the reported incidents are 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: 7" NON-DEHP EXT. SET, MICROCLAVE CONNECTOR
• 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: 19554765
• Report Number: 2025816-2014-00167
• Device Sequence Number: 6805868
• Product Code: FMG
• UDI-Device Identifier: 00887709042438
• UDI-Public: (01)00887709042438
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/17/2014

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 Model Number: 12738
• Device Catalogue Number: 12738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2014
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown