MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, AN; STOPCOCK, I.V. SET

Catalog Number	A1134
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of separation on item a1134 could not be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history record (dhr) was reviewed and no non-conformities were found that would have led the reported complaint.
Event or Problem Description
The reported complaint involved a 99" (251 cm) appx 6.8 ml, transfer set w/check valve, nanoclave® t-connector, anti-siphon valve, 0.2 micron filter, luer lock.It was reported that the thin tubing (that connects the syringe to the main bag of fluid) snapped off while changing the syringe (when twisting off the old syringe) on the 'pn' (possibly tpn, total parenteral nutrition).The event was reported to have occurred 'before infusing, new tubing'.Although there was patient involvement, there was no human harm.

• Brand Name: 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, AN
• 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: 17882189
• Report Number: 9617594-2023-00805
• Device Sequence Number: 7456473
• Product Code: FMG
• UDI-Device Identifier: 00887709069077
• UDI-Public: (01)00887709069077(17)271001(10)10619902
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2023

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: A1134
• Device Lot Number: 10619902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: UNSPEC. 'PN' (LIKELY TPN) INFUSION BAG, MFR UNK; UNSPECIFIED SYRINGE, MFR UNK
• Patient Sex: Unknown