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

Model Number	10010570
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: central venous line;non-bd used microclave;bd 10 ml syringe.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.Additional patient information: (b)(6).
Event or Problem Description
It was reported that while the rn was administering phenobarbital and ativan with a 10cc syringe, the rn noticed a small wet spot on the patient's bed.The rn made a10cc saline flush and while administering the flush observed the saline leaking from the tubing set filter.The tubing set was replaced and the rn reported that she was unsure as to how much phenobarbital or ativan was administered to the infant patient and would monitor the patient for possible increased agitation.
Additional Manufacturer Narrative
The customer¿s report of leaking from the tubing set filter was not confirmed.During visual inspection, it was noted that clear liquid was observed inside the tubing.During functional testing, it was observed that the microclave¿s piston remained recessed after disconnecting the 10ml bd syringe.A leak was observed from the microclave¿s injection port due to the recessed piston not disengaging.Functional testing did not to replicate any leaks within the extension set.Pressure testing also found no anomalies with the returned set.The root cause of the customer¿s report was not identified.
Event or Problem Description
It was reported that while the rn was administering phenobarbital and ativan with a 10cc syringe, the rn noticed a small wet spot on the patient's bed.The rn made a10cc saline flush and while administering the flush observed the saline leaking from the tubing set filter.The tubing set was replaced and the rn reported that she was unsure as to how much phenobarbital or ativan was administered to the infant patient and would monitor the patient for possible increased agitation.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRAITON,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8786901
• Report Number: 9616066-2019-01911
• Device Sequence Number: 2043733
• Product Code: FPA
• UDI-Device Identifier: 10885403236280
• UDI-Public: 10885403236280
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 10010570
• Device Catalogue Number: 10010570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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: 8015,PRI TUBING,8100, TD (B)(6) 2019
• Patient Age: 10 MO