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

Model Number B3300

Device Problems Break (1069); No Flow (2991)

Patient Problems Awareness during Anaesthesia (1707); Therapeutic Response, Decreased (2271)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It is yet to be received.

Event Description

The event occurred on an unknown date.The customer reported that a patient was supposed to be sedated on a propofol drip and was intubated, but was awake because the infusion could go through a broken microclave connector.There was patient involvement but no harm reported.

Manufacturer Narrative

H10: one (1) used list# b3300, clave¿ neutral connector.Lot# 4533763 and one (1) bd syringe 10 ml were received on june 29, 2020 for evaluation.As received, the female luer of one (1) b3300 microclave was broken off into the male luer of the syringe.The broken portion of the female luer could be removed from the male luer.There were two axial cracks on the thread portion of the clave and beach marks were seen on the broken clave.There was also crazing consistent with environmental stress.There was no damage to the internal spike.There was some slit tearing on the top of the silicone seal.No damage or anomalies on the syringe.The syringe was measure and determine to be a compatible mating device.The reported complaint of broken clave can be confirmed on the one (1) b3300 microclave.The probable cause of the damaged clave is typical of environmental stress during use.A device history review for lot# 4533763 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.Received one (1) photo that showed the microclave broken at the top of the clave with the thread inside an unknown male luer.The male luer in the photo was not returned for evaluation.It is unknown if the microclave received is the same one in the photo.

• Brand Name: MICROCLAVE 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: 10218646
• MDR Text Key: 202421902
• Report Number: 9617594-2020-00213
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: (01)00840619045593(17)241201(10)4533763
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B3300
• Device Catalogue Number: B3300
• Device Lot Number: 4533763
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROPOFOL, UNK MFR.