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

Model Number MS3500-15

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report of a small tubing tear was confirmed.The set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures, kinks, holes, and tears in the tubing and its components.Visual inspection of the set noted a tear on the tubing above the male luer.The tear was jagged and uneven at the tear site.No other damages or anomalies were observed.Functional testing confirmed leaking from the tubing tear.The root cause of the damaged tubing could not be determined.

Event Description

It was reported that an unspecified issue occurred involving a secondary set.Although requested, there has been no impact to patient response or additional event information made available to date.

• Brand Name: ALARIS SECONDARY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9849684
• MDR Text Key: 193689512
• Report Number: 9616066-2020-01026
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403222610
• UDI-Public: 10885403222610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS3500-15
• Device Catalogue Number: MS3500-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1