MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MC100

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.The investigation is pending.

Event Description

The event involved a microclave¿ clear neutral connector where it was reported that the clave included inside the cap change kit and implanted vascular access device (ivad) kit becomes lose when attached to the gripper hueber needle.The date of the event occurred during infusion.Over the last few days nurses have been checking the connections and tightening them but when they go back later, they are finding them loose again.The disconnects have been reported with peripheral iv line (piv), peripherally inserted central catheter (picc), and broviac; so the customer does not feel it is the ivad needle connection but the clave cap overall.There was patient involvement, no serious injury or death and no delay in therapy.

Manufacturer Narrative

Received three new sample list #mc100 (3 of lot #5433559, 1 of lot #3771328 and 1 of lot #4529018), one (1) new.List #21-3367-24, smiths medical deltec gripper plus power p.A.C, two (2) new list #0652015, bard power loc safety infusion set (1 of lot #asgtfc087 and 1 of lot#asgufc112), and three (3) new medline kits, 1 of lot #(10)23jbt182, 1 of lot #(10)23ibe771) and 1 of lot #23db0256 were returned for evaluation.As returned no physical damage or anomalies were observed.The male luer of each returned microclaves and the female luer of each mating device measured, finding they meet iso product design specifications.Complaint of disconnection cannot be confirmed or replicated.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18754675
• MDR Text Key: 336760731
• Report Number: 9617594-2024-00173
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100434
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: BROVIAC, MFR UNK.; IMPLANTED VASCULAR ACCESS DEVICE (IVAD), MFR UNK.; PERIPHERAL IV LINE (PIV), MFR UNK.; PERIPHERALLY INSERTED CENTRAL CATHETER, MFR UNK.