MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO; STOPCOCK, I.V. SET

Catalog Number B33895

Device Problem Precipitate in Device or Device Ingredient (1478)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

The event involved a 107" (272 cm) transfer set w/dual check valve, microclave®, luer lock.It was reported started to see some issues when incompatible medications are administered through the line.They administer one medication, do a good flush and then the next one, which may be incompatible.That is when they were noticing precipitate and just had a line clot off.The event occurred while the product was in use with a patient, after a calcium infusion and flush, during the antibiotic infusion.Ms.Shafland stated that there was human harm reported to be associated with the event, it clotted off the line but they were able to save it.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

The possible lot number was reviewed, no nonconformities were identified that may have contributed to the reported complaint.The b33895 transfer set and connected componentry were evaluated and tested and there was no evidence of leakage or precipitate observed.The complaint was unable to be confirmed.

• Brand Name: 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO
• 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: 18223523
• MDR Text Key: 329820892
• Report Number: 9617594-2023-01042
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709072640
• UDI-Public: (01)00887709072640(17)280301(10)13586102
• 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,Followup
• Report Date: 10/31/2023

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: B33895
• Device Lot Number: 13586102.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: CALCIUM INFUSION, MFR UNK; UNSPECIFIED ANTIBIOTIC, MFR UNK