MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 2 GANG 1O2® MANIFOLD, ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	SMV32
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional contact information (b)(6).The device has been received for evaluation, however, investigation is not completed.
Event or Problem Description
The event involved a 2 gang 1o2® manifold, rotating luer where the customer reported that the seal didn't work so fluid went back up into the fentanyl syringe.The other devices that were attached to the monifold are primary plum ivf set and extension set 31inch.The manufacturer and brand name of the syringe is becton, dickinson and company / bd plastipak 5ml syringe.There was patient involvement but no harm reported.
Additional Manufacturer Narrative
Received one (1) used smv32, 2 gang 1o2 manifold for inspection.No defects or anomalies noted.The returned used smv32 2 gang 1o2 manifold was functionally tested and met product performance expectations without leaking past the side port valves.The complaint was unable to be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 2 GANG 1O2® MANIFOLD, ROTATING LUER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 19367254
• Report Number: 9617594-2024-00637
• Device Sequence Number: 14402201
• Product Code: FMG
• UDI-Device Identifier: 00887709042032
• UDI-Public: (01)00887709042032(17)290201(10)13893425
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K974589
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: SMV32
• Device Lot Number: 13893425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: 5ML SYRINGE, BECTON, DICKINSON; PRIMARY PLUM IVF SET AND EXTENSION SET, ICU MEDICA
• Patient Sex: Unknown