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

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 328425479
• Report Number: 9617594-2023-00996
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709125803
• UDI-Public: (01)00887709125803(17)280601(10)13674421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 536035
• Device Lot Number: 13674421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1