MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 104"(264 CM)APPX15.7 ML,10DRP PRIM SET W/BCV-CLAVE,CLAVE,0.2 MIC FILT,ROTAT LUER; 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 104" (264 cm) appx 15.7 ml, 10 drop primary set w/bcv-clave®, clave®, 0.2 micron filter, rotating luer.It was reported that there was a chunk of dark brown material was sticking to the inside of the intravenous (iv) line (near the end of the line).This was noticed after the line was prepared with medication (ampicillin).Once the liquid medication flowed past the brown chunks, some of the particles broke away and it was reported that approximately a dozen were floating in the line.The main chunk of brown material continued to stay adhered to the inside of the line.The iv line was sealed in the packaging when it was received and it was opened about 6pm.There was patient involvement; however, there is no report of human harm.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The device history record (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The complaint cannot be confirmed based on the information that has been provided.After the initial emdr (9617594-2022-00058-00) submission, the customer contact confirmed that the same event was reported under cn-150216, mfr report ref # 9617594-2022-00061-00.This complaint record is a duplicate of cn-150216.

• Brand Name: 104"(264 CM)APPX15.7 ML,10DRP PRIM SET W/BCV-CLAVE,CLAVE,0.2 MIC FILT,ROTAT LUER
• 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: 13864874
• Report Number: 9617594-2022-00058
• Device Sequence Number: 14631813
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2026
• 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: AMPICILLIN, MFR UNK
• Patient Sex: Unknown