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

Model Number	ME1021
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when the nurse was disconnecting the trifuse tubing set from the patient's picc line, the trifuse male luer broke off and was stuck in the bbraun caresite posiflow.There was no report of patient harm.
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
The customer reported that when the nurse was disconnecting the trifuse tubing set from the patient's picc line the trifuse male luer broke off and remained stuck in the bbraun caresite posiflow needleless connector.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 when the nurse was disconnecting the trifuse tubing set from the patient's picc line the trifuse male luer broke off and remained stuck in the braun caresite posiflow needleless connector.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 customer¿s report that the male luer was unable to be disconnected, broke off and remained stuck inside the b.Braun caresite posiflow needleless connector was confirmed.Visual inspection showed that the male luer sub-assembly tip of the set was broken off.Closer microscopic inspection identified the break was uneven and jagged.White stress marks were observed at the corresponding locations of the breakage on the mating luers.Heavy tool marks were observed on the male luer body and stress lines were observed around the rim of the female luer end of the caresite nfv.Other than the damage and observations noted above, there were no other damages or anomalies observed on the remainder of the set.The root cause was identified as the external application of force to the male luer tip.

• Brand Name: EXTENSION SET
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7920204
• Report Number: 9616066-2018-01842
• Device Sequence Number: 1594426
• 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: 10/17/2018; 12/10/2018
• 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: PICC,BBRAUN CARESITE POSIFLOW, TD UNK; PREFILLED SYRINGE, TD (B)(6) 2018
• Patient Age: 3 YR
• Patient Weight: 20