MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 460990471

Device Problems Reflux within Device (1522); Separation Failure (2547)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.E1: additional phone number for reporter: (b)(6).

Event Description

The reported complaint involved a monitoring kit w/safeset¿ ii, 03 ml flush device & marvelous valve.The nurse noted that the arterial line pressure tubing (attached to the patient) became disconnected at the 3-way site, closest to the transducer with the port directed towards the arterial line insertion site (which is not intended to ever come apart) below the luer lock.There is no way to reattach or tighten this connection point.New arterial tubing was exchanged/replaced for the patient.Separation occurred at the upper stopcock near the transducer where the tubing is normally permanently affixed.This pressure tubing is primed by normal saline, and is not traditional intravenous (iv) tubing used for a medication infusion via an infusion pump.The issue occurred approximately 12 hours post-initial tubing priming and use.Only a small amount of blood back up was noted in tubing and was estimated to be less than 20cc.The customer was concerned regarding the potential for significant blood loss if not noticed immediately by the nurse, as the tubing is attached to arterial access site and the set-up is standard pressure tubing with normal saline.There was no patient harm as a result of this reported complaint/event.

Event Description

A medsun mandatory medwatch report (uf/importer report# (b)(4) ) was received on 13-oct-2023 which stated: rn noted that a-line pressure tubing had become disconnected at a site not intended to be able to come apart.At 3-way site closest to transducer, port directed toward a-line insertion site, the pressure tubing had become disconnected.This disconnection occurred below the luer lock, at a part that is not intended to come apart (no way to reattach/tighten connection point).New a-line tubing exchanged to patient and faulty tubing sequestered for pick up by supply chain.Additional event information obtained from ufmw: the report was completed by anna cerilli of yale-new haven hospital.The suspected medical device was a monitoring kit w/safeset¿ ii, 03 ml flush device & marvelous valve with list number 460990471, lot number 13618618, and with common device name transducer, blood-pressure, extravascular.The device is available for evaluation.Moreover, the contact person for this facility is anna cerilli.The location where event occurred was at critical care.

Manufacturer Narrative

The following was returned by the customer for complaint investigation: one used.List #460990471, monitoring kit w/safeset¿ ii, 03 ml flush device & marvelous valve; lot #13618618.A functional pull test was conducted on a representative bond: 13" pressure tubing and female luer.The pressure tubing broke near the male luer at 17.4 lbs within the specifications limit of 6 lbs.Dimensional analysis: od of 45" pressure tubing: 0.113"; spec: 0.111+/-0.003".Female luer: 0.107"; spec: 0.108+/-0.001".Bond depth: 0.2230".Representative bond.Od of 12" pressure tubing: 0.112"; spec: 0.111+/-0.003".Bond depth: 0.2070".The reported complaint of tubing separation was confirmed on the returned set.During visual inspection, the 45" pressure tubing was received separated from the female luer.The end of the tubing was observed to be tacky.The separation of the bond was due to the pressure tubing being tacky.The probable cause of the pressure tubing being tacky is due to the uv adhesive on the tubing not being fully cured during the manufacturing assembly process.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Additional information can be found in b5.Updated information can be found in g1.

• Brand Name: MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 17715295
• MDR Text Key: 323010214
• Report Number: 9617594-2023-00672
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619069087
• UDI-Public: (01)00840619069087(17)260401(10)13618618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

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: 460990471
• Device Lot Number: 13618618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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