MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. BIFUSE EXT SET W/2 MICROCLAVE, 2 CLAMPS, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number B9092

Device Problem Fluid/Blood Leak (1250)

Patient Problems Phlebitis (2004); No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

Plots 3732565 exp date 07/01/2023, 3744593 exp date 07/01/2023, 3702294 exp date 06/01/2023, 3744596 exp date 08/01/2023.Plots 3732565 mfg date 07/01/2018, 3744593 mfg date 07/01/2018, 3702294 mfg date 06/01/2018, 3744596 mfg date 08/01/2018.No product samples, videos, or photographs were returned for investigation.A probable cause cannot be identified based on the information that has been provided.The dhr for lots 3732565, 3744593, 3702294, and 3744596 were reviewed and there were no non-conformances found that would have contributed to the reported complaint.

Event Description

The event involved a bifuse ext set w/2 microclave, 2 clamps, luer lock that on an unspecified date, a leak was observed during an infusion of cytarabine, which was detected in the seal.There was an estimated loss of about 100ml.There was no harm reported.No additional information was provided.

Event Description

Additional information received.The event led to thrombophlebitis in the patient requiring a reinstallation of a heparin infusion catheter and infusion of heparin.

Manufacturer Narrative

It was initially reported the device was not being returned for evaluation.Additional information was received stating a sample is now available for evaluation.It has not yet been received.

Manufacturer Narrative

H10: one (1) used b9092 bifuse extension set was returned for evaluation.The distal male luer was separated at the bond.The bond was evaluated and found to have a solvent ring typical of a good bond, but no visible solvent adhesion in the area of the tubing to male luer bond interface.The probable cause of the bond separation is insufficient solvent coverage at the bond interface during manual assembly.Additional information in h3, h6h11: due to a system limitation, the date in g4 is inadvertently marked as 01/03/2019 in the supplemental emdr.The correct date is 03/01/2019.

• Brand Name: BIFUSE EXT SET W/2 MICROCLAVE, 2 CLAMPS, LUER LOCK
• 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: 8180614
• MDR Text Key: 131387170
• Report Number: 9617594-2018-00228
• Device Sequence Number: 1
• Product Code: FMG
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B9092
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2019
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYTARABINE; CYTARABINE, UNK MFR; UNSP BBRAUN TUBING
• Patient Outcome(s): Required Intervention