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

Model Number	42103E-07
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd syringes not staying connected to the smartsite port below the drip chamber.No patient harm was reported.
Additional Manufacturer Narrative
The customer¿s report that the bd syringes are not staying connected was not confirmed.Functional port did not replicate any instances of disconnection.The received sets were measured and found to be within iso standards.The customer did not send in the syringe that was reportedly disconnecting from the proximal smartsite port.The set were visually inspected for kinks, holes/tears in the tubing or damages to the components.Further functional testing could not be performed due to the set being received damaged during transit.The root cause was not identified.
Event or Problem Description
The customer notified bd with a reported issue of bd syringes that are not staying connected to the smartsite port below the drip chamber.No patient harm was reported.

• Brand Name: ALARIS GRAVITY SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8753166
• Report Number: 9616066-2019-01711
• Device Sequence Number: 2042999
• 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: K931173
• 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: 10/18/2019
• 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: NON BD EXTENSION SET; NON BD EXTENSION SET