MAUDE Adverse Event Report: ICU MEDICAL 38"EXT SET W/4WAY STOPCOCK, WITH Y-CLAVE CONN.; EXT SET WITH Y-CLAVE, 80FMG

Catalog Number B9575

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

Complaint received for the silicone seal protruding outside of the y-clave, within the b9575 extension set.No serious consequences to the patient.

Manufacturer Narrative

Lot number 2919891 showed shows (b)(4) units, b9575, were manufactured, tested, inspected, and released.Functional testing: the silicone seal was protruding from the y-clave assembled into the b9575 extension set.Engineering findings: silicone seal protrusions of this nature can occur when the y-clave assembly is exposed to high back pressures.High back pressures can be generated with small syringes (10cc and smaller).This type of silicone seal protrusion can be prevented if flushing takes place through the y-clave rather than other sites along the fluid path.

• Brand Name: 38"EXT SET W/4WAY STOPCOCK, WITH Y-CLAVE CONN.
• Type of Device: EXT SET WITH Y-CLAVE, 80FMG
• Manufacturer (Section D): ICU MEDICAL; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 4339959
• MDR Text Key: 22268231
• Report Number: 2025816-2014-00133
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: B9575
• Device Lot Number: 2919891
• Other Device ID Number: 27884
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1