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	07/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Section e: additional contacts: (b)(6).
Event or Problem Description
The reported complaint 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 first of two occurrences.
Additional Manufacturer Narrative
One used sample list #mc33332 (connected into 0.9% nacl 250ml bag) was returned and tested for investigation.Although a slow flow was observed at the end of the device, the solution flowed as normal through the filter vent.The set was then cut in the bond areas looking for a partial occlusion and no anomalies were found.The tube was found within specifications and no additional damage or anomaly was observed.The customer's complaint was not confirmed or replicated, as there was nothing wrong with the device's performance upon evaluation.The slow flow at the end of the device was because the length of the tube and the small inner diameter.The device functioned as expected.The lot history was reviewed and no non-conformities were identified that may have contributed to the reported complaint.Updated information can be found in g1.

• 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: 17602634
• Report Number: 9617594-2023-00585
• Device Sequence Number: 15029572
• 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?: Device Returned to Manufacturer
• 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): Yes
• 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