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

Catalog Number 12512-01

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return for evaluation.It has not been received.

Event Description

The event involved a microclave® clear neutral connector that disconnected.The patient called the cancer team at 750am stating that she woke up at 7am and blood was noted to be leaking from the port and the chemo pump was disconnected.The patient stated that she had woke up at 615am to use the bathroom and everything was fine, but when she awoke at 7am, the pump was disconnected from her port.Patient stated that she had reconnected the pump to her port multiple times before she called the cancer team at 750am.The patient stated her pump was still running.She was instructed to stop the pump and clamp the port, cleanse the skin where chemo may have come into contact and remove soiled clothing to be washed separately.The patient was instructed to come to clinic immediately.Upon arrival to clinic, it was found the connections came apart at the microclave clear connection to the port.The patient stated the threads didn't seem like they were staying and that it where it was falling off.The clinician drew back from port to assure there was no air present, received a positive blood return, patient denied any chest pain or shortness of breath, and no pain at site.The port tubing was cleansed thoroughly, and a new microclave clear connector was attached, the port was flushed without complications.There was 9.6ml of 5fu remaining on pump.It was discussed with the pharmacist and provider to infuse the remainder of the 5fu over 2 hours.There was patient involvement, but no harm or adverse event occurred.

Manufacturer Narrative

Additional information can be found in section g1.D10 - date returned to mfg - july 9, 2020.H10 - one used list # 12512-01, microclave¿ clear neutral connector (lot # unknown) was received and visually inspected.As received, the silicone seal was stuck down and torn.No other damage or anomalies were seen.No mating devices were returned.Subsequent disassembly revealed seal tearing and a bent spike.The reported complaint of leaking can be confirmed.The microclave spike and seal damage observed would result in leakage.The probable cause of the seal tearing and bent spike is access with an incompatible mating device during use.The directions for use (dfu) states: the microclave is compatible with luers with an internal diameter (id) between 0.062" and 0.110".Do not use needles or luer caps on claves.The device history review (dhr) review could not be completed since no lot number was provided.

• 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
• MDR Report Key: 10265351
• MDR Text Key: 219567352
• Report Number: 9617594-2020-00232
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 12512-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5FU (FLUOROURACIL), MFR UNK.; CLOSED SYSTEM TRANSFER DEVICE, MFR UNK.; UNSPEC HUBER NEEDLE, MFR UNK.; UNSPEC PUMP, MFR UNK.