MAUDE Adverse Event Report: CAREFUSION ALARIS SECONDARY NON VENTED NEEDLE FREE SET; SET, EXTENSION, INTRAVASCULAR

Model Number 10013364

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

A visual inspection confirmed the customer's report of the roller clamp component missing from the set.The details of this feedback were forwarded to the manufacturing site for investigation.Their analysis confirmed that the missing component is most likely caused by an error made during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.A review did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this case, is evident that this operation was not performed, therefore it can be concluded that yes, it was an operator error.

Event Description

The reported feedback suggests that the clamp is missing.

Event Description

The reported feedback suggests that the clamp is missing.

Manufacturer Narrative

A visual inspection confirmed the customer's report of the roller clamp component missing from the set.The details of this feedback were forwarded to the manufacturing site for investigation.Their analysis confirmed that the missing component is most likely caused by an error made during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.

• Brand Name: ALARIS SECONDARY NON VENTED NEEDLE FREE SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9482143
• MDR Text Key: 190791602
• Report Number: 9616066-2019-03650
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K931550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10013364
• Device Catalogue Number: 10013364
• Device Lot Number: 18085733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1