MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B4018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts were requested for the device to be returned for evaluation.The actual used sample is not available for return; however the manufacturer is attempting to get sister samples from the same lot number from the customer.
Event or Problem Description
The complaint/event involved a 4-way high flow stopcock w/rotating luer that was reportedly leaking norepinephrine from the stopcock plastic hub, however, there no leaks from leur lock connection sites.The patient was receiving this iv medication to maintain cerebral perfusion pressure (cpp) and intracranial pressure (icp) goals.The patient reportedly had a sudden unspecified decrease in cpp, decreased blood pressure (bp), increased icp and also presented oxygen desaturation because the iv medication amount was lower than intended.The customer stated that there was minimal, unspecified harm to the patient.
Additional Manufacturer Narrative
Investigation summary: the complaint on the b4018 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.The customer was asked for sister samples and no response was received.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The dhr for lot 13781156 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/ROTATING 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19939353
• Report Number: 9617594-2024-01099
• Device Sequence Number: 15286741
• Product Code: FMG
• UDI-Device Identifier: 00887709008694
• UDI-Public: (01)00887709008694(17)281001(10)13781156
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080077
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: B4018
• Device Lot Number: 13781156
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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: NOREPINEPHRINE, MFR UNK.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown