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

Model Number	ME1021
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 3)bbraun smallbore filtered extension sets, therapy date (b)(6) 2018.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported that the patient had a double lumen right internal jugular central venous line (rij cvl) with a maxguard trifuse extension set connected to it via a non-bd needleless connector.The trifuse extension set then had three non-bd smallbore filtered extension sets attached to each arm on the trifuse set, infusing milrinone, heparin 5,000u/50ml and heparin 1/2 ns.When the trifuse extension set was disconnected from the non-bd needleless connector, the male luer on the tri-fuse broke off in the non-bd needleless connector and blood leaked onto the patient's bed.The cvl was clampled and the needleless connector was removed.There was no report of patient harm.
Additional Manufacturer Narrative
Patient: infant.The customer¿s report that when the nurse disconnected the trifuse set from the b.Braun caresite posiflow needleless connector, the trifuse male luer broke off and remained stuck inside the b.Braun caresite posiflow needleless connector was confirmed.Visual inspection of the set noted the male luer tip was broken off in another standalone b.Braun caresite needle free valve.Examination under magnification noted the break was uneven and jagged.White stress marks were observed at the corresponding locations of the breakage on the mating luers.Functional testing was deemed unnecessary due to separation.The root cause was identified as the external application of force to the male luer tip created by multiple contributing factors: caresite incompatibility, fusion of luers either from exposure to undried priming liquid or alcohol, weakening of the luer material due to over-exposure to alcohol, hoop stress, over-tightening facilitated by undried priming liquid or alcohol acting as a lubricant, extended use and possible molding defects.
Event or Problem Description
The customer reported that the patient in the picu had a double lumen right internal jugular central venous line (rij cvl) with a maxguard trifuse extension set connected to it via a non-bd needleless connector.The trifuse extension set then had three non-bd smallbore filtered extension sets attached to each arm on the trifuse set, infusing milrinone, heparin 5,000u/50ml and heparin 1/2 ns.When the trifuse extension set was disconnected from the non-bd needleless connector, the male luer on the tri-fuse broke off in the non-bd needleless connector and blood leaked onto the patient's bed.The cvl was clampled and the needleless connector was removed.The customer further states that they do not use alcohol on the male luer when they connect the sets together.The nurse will prime the set with the fluid that will be delivered and then connect the syringe to the set and prime until the fluid exits at the male luer with the duct cap still attached., this is also done for dextrose as well.Before the nurse connects the male luer to an open female luer, the nurse will use a prefilled syringe to place saline into the female luer before connection to ensure that an air bubble is not introduced.There was no report of patient harm.
Event or Problem Description
The customer reported that the patient had a double lumen right internal jugular central venous line (rij cvl) with a maxguard trifuse extension set connected to it via a non-bd needleless connector.The trifuse extension set then had three non-bd smallbore filtered extension sets attached to each arm on the trifuse set, infusing milrinone, heparin 5,000u/50ml and heparin 1/2 ns.When the trifuse extension set was disconnected from the non-bd needleless connector, the male luer on the tri-fuse broke off in the non-bd needleless connector and blood leaked onto the patient's bed.The cvl was clampled and the needleless connector was removed.The customer further states that they do not use alcohol on the male luer when they connect the sets together.The nurse will prime the set with the fluid that will be delivered and then connect the syringe to the set and prime until the fluid exits at the male luer with the duct cap still attached., this is also done for dextrose as well.Before the nurse connects the male luer to an open female luer, the nurse will use a prefilled syringe to place saline into the female luer before connection to ensure that an air bubble is not introduced.There was no report of patient harm.
Additional Manufacturer Narrative
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.

• Brand Name: 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: 7920707
• Report Number: 9616066-2018-01835
• Device Sequence Number: 1937167
• Product Code: FPA
• UDI-Device Identifier: 10885403235955
• UDI-Public: 10885403235955
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2018

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: 10/04/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/16/2018; 12/18/2018
• 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: 8100,8015,PREFILLED SYRINGE; CENTRAL VENOUS LINE,BBRAUN CARESITE NFV, TD (B)(6) 2018
• Patient Age: 20 DA
• Patient Weight: 3