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

Model Number	MZXT9001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 3ml syringe.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that a nicu nurse notice that the gauze on the baby's piv site was wet.Upon flushing, the user observed a leak from the max zero extension (15cm set) at the point where the white plastic and clear plastic meet.The user removed the set and continued iv fluids.Soon after the rn started a gentamicin infusion via 3ml syringe mated to max zero extension set (152 cm).Upon flushing the medication, a leak was noted from the connection between the 3ml syringe and the max zero extension set.The user attempted to tighten the connection however it continued to leak with flushing.The customer confirmed that there was no harm to the baby.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that an (nicu) rn noticed that the gauze on the baby's (piv) site was wet soon after the gentamicin syringe (2ml) infusion was started.Upon flushing the medication bd 3 ml mated to the max zero extension set 152 cm, the user observed a leak from the max zero extension set (15cm) at the point where the white plastic and clear plastic meet.The user tightened the connection, however; it continued to leak with flushing at the spin male luer lock.The user removed the set and continued iv fluids thru the (piv).It was further confirmed during follow up, that there was no patient harm nor impact as a result of this event.(the facility began using mz9267 house wide approximately 1 month.The set was mated to (2 ml) syringe it is connected to the extension tubing (152 cm) which is then connected to the t -connector (15cm) which is connected to the iv catheter).

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR, T
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9324644
• Report Number: 9616066-2019-03303
• Device Sequence Number: 19486890
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: 10885403240805
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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 Expiration Date: 07/31/2021
• Device Model Number: MZXT9001
• Device Catalogue Number: MZXT9001
• Device Lot Number: 18077561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/10/2020
• 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: IV CATHETER; SYR TUBE,8110,8015,(2) FLUSH SYRINGE, TD (B)(6) 2019
• Patient Age: 2 DA
• Patient Weight: 3