MAUDE Adverse Event Report: CAREFUSION ALARIS® EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10010570
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.The event occurred in the nicu; therefore it is presumed the patient was a neonate, race with initial (b)(6) unknown if mom initial or dr.Initials on patient sticker attached to the note received with product.
Event or Problem Description
Product received unexpectedly, there was a note attached with the returned product stated; "was pushing a med when filter cracked." a patient information sticker attached to the note stated that the event occurred in the nicu.Although requested the customer did not indicate any patient harm.
Additional Manufacturer Narrative
The customer¿s report of a cracked filter was not confirmed but a leak from the weld line was confirmed.Inspection of the sample showed no obvious issues with the filter component; however, testing resulted in fluid leaking from the filter's weld line.The root cause of the weld line leak is a supplier manufacturing issue.
Event or Problem Description
Product received unexpectedly , there was a note attached with the returned product stated; "was pushing a med when filter cracked." a patient information sticker attached to the note stated that the event occurred in the nicu.Although requested the customer did not indicate any patient harm.

• Brand Name: ALARIS® EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8283245
• Report Number: 9616066-2019-00181
• Device Sequence Number: 11184082
• Product Code: FPA
• UDI-Device Identifier: 10885403233500
• UDI-Public: 10885403233500
• 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: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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: 01/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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: MICROCLAVE,THERAPY DATE: UNK.