MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14 CM (5.5") SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE CLEAR, 2 CLAMPS, ROTATING; STOPCOCK, I.V. SET

Catalog Number 011-MC33126

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation.It has not been received.

Event Description

The event involved a 14 cm (5.5") smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer that the customer reported a rupture at the level of the valve tubing junction, during insertion and outside of any traction.Lidocaine, ketamine, propofol, capressan, cafozine, and esmeron were infusing through a connector.There was patient involvement with no report of harm, no clinical consequences to the patient, no delay of therapy, nor blood loss; however, the customer reported a need for an unspecified medical intervention.The device was replaced.No additional information has been provided.

Manufacturer Narrative

H10: received one used list# 011-mc33126, 14 cm (5.5") smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer.Lot# 4850373 on january 18, 2021 for evaluation and visually inspected.A photograph was provided and evaluated.The photo shows a bifuse extension set.The tubing appears to be separated from the shuntless microclave.No other damage or anomalies on the set can be seen in the image.As received, the tubing was separated from the bond pocket of one of the two microclaves on the set.Little to no solvent was present on the separated components.No other damage or anomalies were observed.The dimensions of the separated parts were measured and found to meet design specifications.The reported complaint of a bond separation can be confirmed.The probable cause is due to an error during the manual assembly process.A device history review (dhr) lot# 4850373 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 14 CM (5.5") SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE CLEAR, 2 CLAMPS, ROTATING
• 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
• MDR Report Key: 10985031
• MDR Text Key: 220723066
• Report Number: 9617594-2020-00534
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058692
• UDI-Public: (01)00840619058692(17)250501(10)4850373
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33126
• Device Lot Number: 4850373
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 01/24/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAFOZINE, MFR UNK; CATAPRESSAN, MFR UNK; ESMERON, MFR UNK; KETAMINE, MFR UNK; LIDOCAINE, UNK MFR; PROPOFOL, UNK MFR; CAFOZINE, MFR UNK; CATAPRESSAN, MFR UNK; ESMERON, MFR UNK; KETAMINE, MFR UNK; LIDOCAINE, UNK MFR; PROPOFOL, UNK MFR