MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLA; STOPCOCK, I.V. SET

Catalog Number MC330479

Device Problem Break (1069)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Initial reporter full phone # + (b)(6).Additional contact: (b)(6).The stevens company limited.E3 - corrective actions taken none at this time.E2 - root cause of problem.

Event Description

The complaint/event involved a 7" (18 cm) appx 0.62 ml, smallbore quadfuse ext set w/4 microclave® clear, 4 clamps, luer lock that was reported to be broken at the quad site.At the time there was only normal saline in the line.It was unknown if there was a patient involved in the event, however there was no report of human harm.

Manufacturer Narrative

The complaint of broken item mc330479 cannot 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 was reviewed and no non-conformities were found that would have led the reported condition on the complaint.

• Brand Name: 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLA
• 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: 18385406
• MDR Text Key: 331500471
• Report Number: 9617594-2023-01191
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709090200
• UDI-Public: (01)00887709090200(17)280201(10)13551242
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: MC330479
• Device Lot Number: 13551242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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
• Treatment: NORMAL SALINE, MFR UNK