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

Model Number	10796812
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: 250ml braun bag, lot: j9n180, exp: 10/21, 0.9% nacl injection; bd catheter.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Although requested, no patient information provided.
Event or Problem Description
It was reported that there was a gravity tubing leak.The event occurred on a pet/ct unit, during an administration of "f18 fluorodeoxyglucose (radioactive fluorine)," given with 21 gauge needle using 3 ml syringe.There was no patient harm or adverse effects as a result of this event.The event did not cause a significant change in course of treatment for the patient, nor require medical or surgical intervention as a result.There was no user harm.Although requested, customer unable to provide patient information.
Additional Manufacturer Narrative
The customer¿s report of a gravity tubing leak at the injection port was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No abnormalities were observed on the sets during visual inspection.Visual inspection of the associate sets noted clear liquid in the set¿s drip chamber and entire length of tubing.Functional and pressure testing resulted in no leaking.Photo provided by the customer shows leaking at the injection port of a gravity tubing.The root cause was not identified.
Event or Problem Description
It was reported that there was a gravity tubing leak.The event occurred on a pet/ct unit, during an administration of "f18 fluorodeoxyglucose (radioactive fluorine)," given with 21 gauge needle using 3 ml syringe.There was no patient harm or adverse effects as a result of this event.The event did not cause a significant change in course of treatment for the patient, nor require medical or surgical intervention as a result.There was no user harm.Although requested, customer unable to provide patient information.

• 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: 9717602
• Report Number: 9616066-2020-00476
• Device Sequence Number: 353660
• Product Code: FPA
• UDI-Device Identifier: 10885403234316
• UDI-Public: 10885403234316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 10796812
• Device Catalogue Number: 10796812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: 21 GAUGE NEEDLE,3ML SYRINGE, TD UNK