MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60IN/152.4CM EXT. W/M/FLL CLAMP APV=1.0ML; STOPCOCK, I.V. SET

Catalog Number	536035
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on unknown date involving a 60in/152.4cm ext.W/m/fll clamp apv=1.0ml where it was reported that the customer was unable to flush through the tubing by manual push.There was unknown patient involvement and unknown human harm reported.
Additional Manufacturer Narrative
E1 - initial reporter phone has an extension (b)(6).The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.

• Brand Name: 60IN/152.4CM EXT. W/M/FLL CLAMP APV=1.0ML
• 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: 18162046
• Report Number: 9617594-2023-00996
• Device Sequence Number: 7216046
• Product Code: FMG
• UDI-Device Identifier: 00887709125803
• UDI-Public: (01)00887709125803(17)280601(10)13674421
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/17/2023

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: 536035
• Device Lot Number: 13674421
• 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: 10/06/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Patient Sex: Unknown