MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 011-CH3687

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The complaint/event occurred on an unspecified date and involved a 41 cm (16") bifuse add-on set w/2 bag spikes, 2 clamps (red, blue), vented cap.The nurse reported that when she touched the line (bifuse) to the normal saline bag, it disconnected from the spike.Because the spike broke off, normal saline leaked onto the floor, whilst the infusion kept running.The infusion was completed, and an unspecified non-chemotherapy bag was replaced with normal saline for a flush.Treatment completed.There was no harm reported with respect to this complaint/event.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Manufacturer Narrative

The following items were provided/returned by the customer for investigation: one new list #011-ch3687, 41 cm (16") bifuse add-on set w/2 bag spikes, 2 clamps (red, blue), vented cap; lot #13723509.One used list #011-ch3687, 41 cm (16") bifuse add-on set w/2 bag spikes, 2 clamps (red, blue), vented cap; lot #13723509.One used list #unknown, extension set w/ filter; lot #unknown.One used list #unknown, extension set w/ 4-way stopcock; lot #unknown.One used list #unknown, bag spike adaptor; lot #unknown.One used list #unknown, 0.9% sodium chloride 100ml bag; lot #82sc695103.One used list #unknown, 0.9% sodium chloride 250ml bag; lot #82sh795305.The used sets had a separation from the bag spike on one of the lines.Evaluation of the bond under ultraviolet light showed gaps in solvent coverage.No defects or anomalies on the new set.The tubing and bond pocket were measured and found to meet dimensional specifications.Subsequent bond integrity testing on an adjacent bond and on the new sets met performance expectations.The reported complaint of a separation can be confirmed on the used set.The probable cause is due to insufficient solvent coverage during manual assembly during manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 18mar2024.

• Brand Name: 41 CM (16") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), VENTED CAP
• 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: 18763375
• MDR Text Key: 336982644
• Report Number: 9617594-2024-00186
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-CH3687
• Device Lot Number: 13723509
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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: INTRAVENOUS (IV) BAG OF NORMAL SALINE, MFR UNK; UNSPECIFIED NON-CHEMOTHERAPY IV BAG, MFR UNK