MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) APPX 0.29 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, 2 CLAMPS, LUE; STOPCOCK, I.V. SET

Catalog Number B33876

Device Problems Crack (1135); Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received for investigation.Investigation is pending.

Event Description

The event occurred on various dates (b)(6) 2023 and (b)(6) 2023 and involved a 5" (13 cm) appx 0.29 ml, smallbore bifuse ext set w/2 microclave¿, 2 clamps, luer lock where it was reported that the microclave remains depressed while in use.In some cases, this has caused leaking and disconnection during infusions to central lines.There have also been events of breakage of the hard plastic portion of the microclave.This was a trend that they noticed in the past few weeks.The event occurred while the product was in use with a patient, and unknown human harm.

Manufacturer Narrative

Received: one used.List #b33876, 5" (13 cm) appx 0.29 ml, smallbore bifuse ext set w/2 microclave¿, 2 clamps, luer lock; lot #unknown.Two new.List #b33876, 5" (13 cm) appx 0.29 ml, smallbore bifuse ext set w/2 microclave¿, 2 clamps, luer lock; lot #13477293.One new.List #b33876, 5" (13 cm) appx 0.29 ml, smallbore bifuse ext set w/2 microclave¿, 2 clamps, luer lock; lot #13590157.One used and three new samples different lots were returned for evaluation.As received the used sample present stick down condition on both claves.No mating device was returned for evaluation.The new samples were activated once, and no stick down condition was confirmed, the claves of the used sample were dissembled, and an intermittence of lubrication was observed on both spikes and a slit propagation on seal as well.The shuntless from the three new samples were dissembled and an intermittence of lubrication on spike were observed on spike #2 from sample #2.Complaint of silicone sleeve stuck down can be confirmed.The probable cause of the intermittences observed on the spike is typically due to an error during automated process.A device history review (dhr) lot #13477293 and #13590157 were reviewed and no relevant commodities, discrepancy or anomalies were confirmed that might lead the condition reported by customer.

• Brand Name: 5" (13 CM) APPX 0.29 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, 2 CLAMPS, LUE
• Type of Device: STOPCOCK, I.V. SET
• 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: 18050241
• MDR Text Key: 327392477
• Report Number: 9617594-2023-00915
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: B33876
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTRAL LINE, UNK MFR.