MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE MODULE SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10798696
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that they are experiencing multiple events in which the pressure sensing disc leaks during patient use.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of the set leaking was confirmed.However, the leak was observed on the filter and not the pressure sensing disc.Visual inspection of the set showed that the microbore tubing had not been fully inserted into the filter outlet port.Examination under magnification showed that both sides of the tubing had insufficient solvent applied at the engagement.Functional testing confirmed leaking from the microbore tubing to the outlet port of the filter.No leaks were observed on the pressure sensing disc.Dimensional analysis was performed and the tubing measured within specification.The root cause of the customer¿s report was a manufacturing issue due to insufficient solvent being applied at the junction of the microbore tubing and the tubing not being pushed all away into the filter outlet port.
Event or Problem Description
The customer reported that they are experiencing multiple events in which the pressure sensing disc leaks during patient use.There was no patient harm.

• Brand Name: ALARIS SYRINGE MODULE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7997198
• Report Number: 9616066-2018-01983
• Device Sequence Number: 289334
• Product Code: FPA
• UDI-Device Identifier: 10885403234354
• UDI-Public: 10885403234354
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: 04/18/2021
• Device Model Number: 10798696
• Device Catalogue Number: 10798696
• Device Lot Number: 18046218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8110,8015,BD SYRINGE 60ML, TD UNK