MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11 CM (4.5") APPX 0.31 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿, 2 CLAMPS, R; STOPCOCK, I.V. SET

Catalog Number IA-C3322

Device Problems Break (1069); Fluid/Blood Leak (1250); Component Missing (2306)

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

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a 11 cm (4.5") appx 0.31 ml, smallbore bifuse ext set w/2 microclave¿, 2 clamps, rotating luer.It was reported leakage and breakage and it was noted that a male connector part was missing.Upon checking the surface of tube cut section and the cut section inside the connector, patterns characteristic to tensile fracture were observed.The shape of tube tip indicates a trace of being torn apart.Connected a syringe to the valve of detached connector and checked liquid flow.Leakage was confirmed." it was also mentioned that the event was not detected prior to patient use.The event occurred during infusion.There was patient involvement however no part harm was reported.The device was changed out/replaced with no further problems encountered.

Manufacturer Narrative

A couple of photos were shared by customer, where a multiple tubing break separation of item #ia-c3322 are observed.One (1) used sample item #ia-c3322 without male luer adaptor was returned for evaluation, as received the microclaves came separated from the set and it was confirmed a remaining part of the tube inside the microclave.No mating device was returned.There was not enough presence of solvent on the tube where the male luer adaptor was missing.How, where or when the male luer adaptor got missing cannot be determined.Complaint of leaks can be confirmed due to tubing break.The probable cause of tubing break after being analyzed is typical due to an unintentional puling force during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 11 CM (4.5") APPX 0.31 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿, 2 CLAMPS, R
• 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: 17710770
• MDR Text Key: 322954059
• Report Number: 9617594-2023-00664
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619099206
• UDI-Public: (01)00840619099206(17)280101(10)13514618
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IA-C3322
• Device Lot Number: 13514618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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: UNSPECIFIED SYRINGE, MFR UNK