MAUDE Adverse Event Report: CAREFUSION MAXGUARD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number ME1110

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

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.No additional information was available.

Event Description

Unexpected return - it was reported from the nicu that the iv tubing was missing the male luer.Per customer, no additional information is available.

Manufacturer Narrative

The customer reported of iv tubing missing male luer was confirmed and identified to be a cracked male luer hub.It was observed that the received set sample's male luer collar was damaged.No testing was deemed necessary due to the obvious damage.Device history record for model me1110 lot 19106625 shows that the set was manufactured on 19 october 2019 with a total of 12,003 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.The root cause was design of the male luer component.

Event Description

Unexpected return - it was reported from the nicu that the iv tubing was missing the male luer.Per customer, no additional information is available.

• Brand Name: MAXGUARD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10044857
• MDR Text Key: 200464391
• Report Number: 9616066-2020-01526
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236044
• UDI-Public: 10885403236044
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ME1110
• Device Catalogue Number: ME1110
• Device Lot Number: 19106625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, 8100, THERAPY DATE: UNKNOWN; GREEN CUROS CAP