MAUDE Adverse Event Report: CAREFUSION ALARIS GRAVITY SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	42103E-07
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
Concomitant medical products: 10 ml bd syringe 0.9%, sodium chloride injection, lot 9099604, exp 2022-03-31.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Although requested, patient demographic details were not provided.
Event or Problem Description
The customer notified bd with a reported issue of a set leaking at the fixed collar above spin collar.There was no patient harm reported.
Event or Problem Description
The customer notified bd with a reported issue of a set leaking at the fixed collar above spin collar.There was no patient harm reported.
Additional Manufacturer Narrative
The customer¿s report of a set leaking at the fixed collar above spin collar was confirmed due to a leak from the set¿s male luer.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear fluid was observed inside the tubing throughout the set.No damages or anomalies were observed during inspection.Functional testing was performed and a leak was observed from the gap within the collar of the 2-piece male luer and the outer walls of the male luer¿s inlet port.Closer inspection confirmed that the leak was observed from the male luer component.The set was pressure tested and the set leaked from within the male luer¿s collar and no other leaks were observed.The root cause of the leak is due to a supplier manufacturing error by supplier.

• Brand Name: ALARIS GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8753172
• Report Number: 9616066-2019-01712
• Device Sequence Number: 16625680
• Product Code: FPA
• UDI-Device Identifier: 10885403225840
• UDI-Public: 10885403225840
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 05/14/2019

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 Model Number: 42103E-07
• Device Catalogue Number: 42103E-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 10/09/2019
• 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: EL-NC1001,BD 10 ML FLUSH SYRINGE; EL-NC1001,BD 10 ML FLUSH SYRINGE