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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned.It has not yet been received.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9617594-2018-00221
• Device Sequence Number: 295294
• Product Code: FMG
• UDI-Device Identifier: 00887709089174
• UDI-Public: (01)00887709089174(17)230901(10)3782764
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: CH3699
• Device Lot Number: 3782764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1