MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC33332
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reported complaint occurred on an unspecified date and involved a 128" (325 cm) appx 9.3 ml, transfer set w/microclave® clear, dual check valve, smallbore bifuse ext set w/microclave® clear (green ring), 0.2 micron filter, rotating luer.The customer reported that per their troubleshooting, it was revealed that the iv tubing caused the syringe pump to ring as occluded and it was not due to the piv itself causing any high pressure.The green air filter 0.2 micron filter had white precipitate in it.The patient was on penicillin g with a normal saline med line only used for medicine administration, not continuous infusions.The impact of the incident is that a new bifuse was hung and the remainder of medicine was given via new line.There was no apparent harm that reached a person.This emdr reflects the second of two occurrences.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Section e: additional contacts: (b)(6).
Additional Manufacturer Narrative
The device is no longer available for investigation.Without the return of the device a probable cause is unable to be determined.The lot history was reviewed and no non-conformities were identified that may have contributed to the reported complaint.

• Brand Name: 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17602681
• Report Number: 9617594-2023-00586
• Device Sequence Number: 12339297
• Product Code: FMG
• UDI-Device Identifier: 00887709037816
• UDI-Public: (01)00887709037816(17)280201(10)13551112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: MC33332
• Device Lot Number: 13551112
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: PENICILLIN G, MFR UNK.
• Patient Sex: Unknown