MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS W/RED CAP; STOPCOCK, I.V. SET

Catalog Number CH3699

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned.It has not yet been received.

Event Description

The event involves a smallbore bifuse ext set w/2 chemoclave®, spiros® w/red cap, 2 clamps that during disconnection a leak of vincristine was noticed.There was patient involvement, drug exposure to the patient, family, and staff, unknown adverse event, and a potential risk for central line associated bloodstream infection (clabsi).No additional information has been received.

Manufacturer Narrative

No samples were provided and no photographs were provided for investigation.A review of similar investigations from the same facility for the same device with same lot number confirmed the disconnects on the returned samples for the spinning spiros is due to no solvent observed at the bond interface of the male luer at the distal end.The probable cause of the component separation is a bonding error during the manual bonding process.Based upon this information the complaint is therefore considered confirmed.The lot # 3782764 and relevant commodities were reviewed and there were no non-conformances found.

• Brand Name: SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS W/RED CAP
• 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: 8152274
• MDR Text Key: 130642079
• Report Number: 9617594-2018-00221
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709089174
• UDI-Public: (01)00887709089174(17)230901(10)3782764
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: CH3699
• Device Lot Number: 3782764
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1