MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.67ML EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC3325
Medical Device Problem Codes	Fluid/Blood Leak (1250); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18cm) appx 0.69ml ext set w/remv microclave¿ clear, clamp, rotating luer in which the customer reported that while drawing bloodwork with a saline lock, the end of the luer lock (attached the tubing) blew off independently while still attached to the vacutainer.The vacutainer with the lavender syringe was thrown onto the floor and blood from the patient sprayed on to the floor and blood was dripping from the patient (unspecified amount).The saline tubing was clamped off, another member of staff was called to get additional supplies.There were no defects noted on the tubing set before it was used.The tubing was replaced and therapy resumed.The incident occurred during patient use (in isolation) but no harm was reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.(b)(6).

• Brand Name: 7" (18CM) APPX 0.67ML EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): 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 ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17961479
• Report Number: 9617594-2023-00849
• Device Sequence Number: 5119192
• Product Code: FPA
• UDI-Device Identifier: 00887709037540
• UDI-Public: (01)00887709037540(17)280301(10)13589361
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2023

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 Catalogue Number: MC3325
• Device Lot Number: 13589361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: SALINE LOCK, MFR UNK; VACUTAINER, MFR UNK
• Patient Sex: Unknown