MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.69 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC9004
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Additional information e1: (b)(6).
Event or Problem Description
It was reported, on an unknown date, a 9" (23 cm) appx 0.77 ml, pressure infusion (400psig) ext set w/remv microclave¿ clear, clave¿ clear, clamp, rotating luer was found defective in the emergence department with the inner part of the adapter coming out of the housing during use.There was no patient harm reported.
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where two (2) samples are observed, the first one is an item #mc9004 with a tag say "normal" and the second one is a single microclave with a seal protrusion and a tag say "defective".The defective microclave of item #mc9004 was returned for evaluation, a seal protrusion was observed on the microclave and an internal dry solution inside the body was observed.Complaint of defective/malfunctioning components can be confirmed based on the physical sample evaluation.The probable cause is typically due to overpressure of the device without activating the clamp.According to dfu statement.For sets equipped with clave/ microclave y site: prior to pressurizing, activate the slide clamp and give the pressure infusion through the clave/ microclave y site.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Additional information: d9 - date returned to mfg: 8/21/2023.

• Brand Name: 9" (23 CM) APPX 0.69 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17548669
• Report Number: 9617594-2023-00550
• Device Sequence Number: 15124421
• Product Code: FPA
• UDI-Device Identifier: 00887709039315
• UDI-Public: (01)00887709039315(17)280101(10)13515277
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: MC9004
• Device Lot Number: 13515277
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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
• Patient Sex: Unknown