MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MZ9277
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: non-bd connector; bd 10ml syringe, lot: 9115975, exp: 2022-04-30, 0.9% sodium chloride injection.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 neonatal icu the 3ml syringes were leaking with the needleless valve and needleless valve microbore tubing.The customer states that there was no medical intervention or adverse event.
Additional Manufacturer Narrative
The customer¿s report that the 3ml syringes were leaking was confirmed.Visual inspection of the 3ml syringe noted deformed sections near the base of their luer tips.Examination under magnification of the syringe observed a deformed section (flat area) on the conical luer near the base of the luer tip.This flat area would create a leak path as this is a critical surface in order to seal with specific mating components.There were no other anomalies observed.Functional and pressure testing confirmed leaking at the engagement between the two components.The root cause was identified as due to damaged syringe luer tips.The cause of the damaged syringe luer tips is unknown.No issues were observed with the reported suspect sets (mz9267) and (mz9277).
Event or Problem Description
It was reported that in the neonatal icu the 3ml syringes were leaking with the needleless valve and needleless valve microbore tubing.The customer states that there was no medical intervention required or adverse event to the patient.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8907831
• Report Number: 9616066-2019-02358
• Device Sequence Number: 2716822
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: 10885403240799
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: MZ9277
• Device Catalogue Number: MZ9277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2019
• 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: (5) BD 3ML SYRINGE, THERAPY DATE (B)(6) 2019