MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (17 CM) APPX 0.35 ML, SMALLBORE PRESSURE INFUSION (400 PSIG) EXT SET W/REMV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	A1201
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 6.5" (17 cm) appx 0.35 ml, smallbore pressure infusion (400 psig) ext set w/remv microclave¿ clear, nanoclave¿, purple clamp, rotating luer.The reporter stated that when the rn went to the flush saline through a patient's unspecified iv line, there was pressure in the line and fluid came out of microclave port.There was no patient harm, injury or adverse event.
Additional Manufacturer Narrative
A series of photos were shared by the customer, where different conditions of the set is shown.However, the most representative one is where the seal is observed to be protruding from a nanoclave.One used sample item #a1201 was returned for evaluation.As received, the silicone was observed to be protruding out of the nanoclave device.Some parts of the tube were observed to be tacky, due to a piece of tape that was placed.No mating devices were returned.The customer's complaint can be confirmed based on the physical sample evaluation and photos shared by the customer for evaluation.The probable cause is typically due to overpressure on the device without activating the clamp.According to the directions for use (dfu): 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.A device history record review could not be conducted because no lot number was identified.

• Brand Name: 6.5" (17 CM) APPX 0.35 ML, SMALLBORE PRESSURE INFUSION (400 PSIG) EXT SET W/REMV
• 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: 20788342
• Report Number: 9617594-2024-01692
• Device Sequence Number: 12714912
• Product Code: FPA
• UDI-Device Identifier: 00887709080393
• UDI-Public: 00887709080393
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: A1201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE FLUSH, MFR UNK; PATIENT'S UNSPECIFIED IV LINE, MFR UNK
• Patient Sex: Unknown