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

Model Number	ME1110
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10044857
• Report Number: 9616066-2020-01526
• Device Sequence Number: 2911233
• Product Code: FPA
• UDI-Device Identifier: 10885403236044
• UDI-Public: 10885403236044
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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 Expiration Date: 10/19/2024
• 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: 8015, 8100, THERAPY DATE: UNKNOWN; GREEN CUROS CAP