MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 104" (264 CM) APPX 15.7 ML, 10 DROP PRIMARY SET W/BCV-CLAVE®, CLAVE®, 0.2 MICRON; STOPCOCK, I.V. SET

Model Number	B9535
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 104" (264 cm) appx 15.7 ml, 10 drop primary set w/bcv-clave®, clave®, 0.2 micron filter, rotating luer that the customer reported particulate on the tubing upon opening and the event was noticed prior to attaching on the patient.The tubing set was connected to a minibag plus system.There was no patient involvement and no harm reported.
Additional Manufacturer Narrative
The device was received for evaluation.Investigation is pending.
Additional Manufacturer Narrative
Received one used list #b9535, 104" (264 cm) appx 16.3 ml, 10 drop primary set w/2 clave¿, 0.2 micron filter, 2 check valves, rotating luer; lot #5556559, one used list #unknown, 0.9% sodium chloride injection usp mini-bag plus container baxter 100 ml intravenous bag; lot #p422192, one used list #unknown, ampicillin for injection, usp 2 grams/vial mylan institutional llc vial; lot #7105133.A single used b9535 infusion set was returned and confirmed with a black embedded particle in the male spin luer assembly.A series of photos were returned showing what appears to be a black embedded particle in the male spin luer assembly.The embedded particle was not in the fluid path and is considered a cosmetic defect.Though the black particle was not in the fluid path it does not meet meet visual inspection criteria.The probable cause is burnt embedded plastic during the molding process.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
Additional information received from a medwatch report (mw5107905) that stated, "icu medical tubing b9535, lot 555659 is reported to have both large and small particulate matter in the tubing upon opening.Fda safety report id # (b)(4)¿.Outcomes attributed to adverse event: other serious or important medical event.The suspect medical device is an administration set 104".

• Brand Name: 104" (264 CM) APPX 15.7 ML, 10 DROP PRIMARY SET W/BCV-CLAVE®, CLAVE®, 0.2 MICRON
• Common Device Name: 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: 13874446
• Report Number: 9617594-2022-00061
• Device Sequence Number: 17316554
• Product Code: FMG
• UDI-Device Identifier: 00887709014343
• UDI-Public: (01)00887709014343(17)260801(10)5556559
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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 Expiration Date: 08/01/2026
• Device Model Number: B9535
• Device Catalogue Number: B9535
• Device Lot Number: 5556559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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: MINIBAG PLUS SYSTEM, MFR UNK.
• Patient Sex: Unknown