MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 138" (350 CM) APPX 18.4 ML 15 DROP ADMIN SET W/3 CLAVE¿, CHECK VALVE, FLOW CONTR; STOPCOCK, I.V. SET

Model Number B33959

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Event Description

The event involved a 138" (350 cm) appx 18.4 ml 15 drop admin set w/3 clave¿, check valve, flow controller, 2 gang 4-way clave¿ stopcock, spin luer w/filter cap, 1 ext, drop-in ext set w/remv clave¿, spin luer w/filter cap where it was reported particulate matter was found in the set.The customer stated there was black matter that was located in the drip chamber.The event occurred when it was opened and still in the package.There was no patient involvement and no patient harm.

Manufacturer Narrative

Received one used.List #b33959, 138" (350 cm) appx 18.4 ml 15 drop admin set w/3 clave¿, check valve, flow controller, 2 gang 4-way clave¿ stopcock, spin luer w/filter cap, 1 ext, drop-in ext set w/remv clave¿, spin luer w/filter cap; lot #8602283.One used.List #unknown, lactated ringer's injection 1000ml bag; lot #5376760.Burnt plastic particles were confirmed to be embedded within the cylinder walls of the drip chamber.The burnt plastic was not exposed to the fluid path.The probable cause is a molding anomaly during plastic injection molding.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to mfr on 1/5/2023.

• Brand Name: 138" (350 CM) APPX 18.4 ML 15 DROP ADMIN SET W/3 CLAVE¿, CHECK VALVE, FLOW CONTR
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16102435
• MDR Text Key: 308067790
• Report Number: 9617594-2023-00017
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709121423
• UDI-Public: (01)00887709121423(17)270901(10)8602283
• 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
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33959
• Device Catalogue Number: B33959
• Device Lot Number: 8602283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1