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

Model Number MZ9226

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

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.Although requested, patient demographics was not provided.

Event Description

It was reported that there was some leaking noted at the filter upon start of iv caffeine citrate infusion.It was observed a small dot on the filter where the leak was noted.The event occurred in neonatal intensive care unit (nicu).There was no patient injury.Although requested, additional information was not provided.

Manufacturer Narrative

Additional information provided; d.10, & d.11.The customer¿s report of a leak at the filter was not confirmed.The set was inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection under magnification of the micron filter observed no obvious issue or damage.Further visual inspection under magnification of the recently mated components observed no obvious damages or issues the syringe was filled with fluid and the fluid was pushed through the set and no leak was observed.Pressure testing resulted in no leaking.The root cause was not identified.

Event Description

It was reported that there was some leaking noted at the filter upon start of iv caffeine citrate infusion.It was observed a small dot on the filter where the leak was noted.The event occurred in the neonatal intensive care unit (nicu).It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.Although requested, additional event information was not provided.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR,.F
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9532776
• MDR Text Key: 193983817
• Report Number: 9616066-2019-03776
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240621
• UDI-Public: 10885403240621
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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
• Device Operator: Health Professional
• Device Model Number: MZ9226
• Device Catalogue Number: MZ9226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 ML BD SYRINGE, THERAPY DATE (B)(6) 2019.