MAUDE Adverse Event Report: CAREFUSION MAXGUARD MINIBORE TRI-FUSE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	ME1021
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	05/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 10 ml bd syringe, lot 8340706, exp 2021-11-30.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that in the nicu, the rn noted blood in the bed and blood backing up in the tubing.The medication line was clamped, and the leakage was found to be at the "clc" connection to the medication line, and also where the medication line attached to the y-site.The tubing was changed.This was reported as an "unsafe condition (non event)".
Additional Manufacturer Narrative
The customer¿s report of leaks was confirmed.Inspection noted a crack along the side of model me1021's female luer.During functional testing, liquid leaked from the crack.No other leaks were observed.Further inspection noted a crack in the female luer of model me1021.No other obvious damages or any issues were observed on the rest of the received sample's components.Each of the 2000e's ends were observed to be within iso specification when measured the cause of the leak was due to a cracked female luer.The root cause of the crack was not identified.
Event or Problem Description
It was reported that in the nicu, the rn noted blood in the bed and blood backing up in the tubing.The medication line was clamped, and the leakage was found to be at the "clc" connection to the medication line, and also where the medication line attached to the y-site.The entire tubing set was changed.This was reported as an "unsafe condition (non event)".Although requested, there was no additional information provided.

• Brand Name: MAXGUARD MINIBORE TRI-FUSE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8791409
• Report Number: 9616066-2019-01947
• Device Sequence Number: 1977338
• Product Code: FPA
• UDI-Device Identifier: 10885403235955
• UDI-Public: 10885403235955
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Model Number: ME1021
• Device Catalogue Number: ME1021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: 2000E, PICC LINE ,THERAPY DATE (B)(6) 2019
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Age: 10 DA