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

Model Number 42521E

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that during priming and prior to patient use, leak was observed as the distal luer connector of the stopcock would not tighten.The event occurred at rehabilitation and orthopedic institute.There was no patient harm.

Event Description

It was reported that during priming and prior to patient use, a leak was observed as the distal luer connector of the stopcock would not tighten.The event occurred at the rehabilitation and orthopedic institute.As this event occurred during priming there was no patient involvement associated with this event, and subsequently; no patient harm or impact as a result.

Manufacturer Narrative

The customer's report of leak was observed as the distal luer connector of the stopcock and would not tighten was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or loose components.No abnormalities were observed during visual inspection.No issues were observed during functional testing of the received set.Dimensional evaluation determined that primary male luer was within iso specification(s).The root cause of the customers reported was not identified.

• Brand Name: ALARIS GRAVITY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9806344
• MDR Text Key: 191710438
• Report Number: 9616066-2020-00731
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403274251
• UDI-Public: 10885403274251
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42521E
• Device Catalogue Number: 42521E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1