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

Model Number	MPX5300-C
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the extension set was leaking at connection to the catheter.It was noted hat the threads were no threading accurately and cracks were observed.There were no adverse effects caused to any patients from the event."this file captures the several and repeated issues that were not reported.".
Event or Problem Description
It was reported that the extension set was leaking at connection to the catheter.It was noted that the threads were no threading accurately and cracks were observed.There were no adverse effects caused to any patients from the event."this file captures the several and repeated issues that were not reported.".
Additional Manufacturer Narrative
The customer complaint of extension set was leaking at connection to the catheter could not be confirmed due to the product was not returned for failure investigation.No investigation was performed.Device history record for model mpx5300-c lot 20016223 shows that the set was manufactured on 14 january 2020 with a total of (b)(4) units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.The root cause of this failure was not identified as no product was returned.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10106069
• Report Number: 9616066-2020-01853
• Device Sequence Number: 3408651
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: 10885403237218
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 01/14/2025
• Device Model Number: MPX5300-C
• Device Catalogue Number: MPX5300-C
• Device Lot Number: 20016223
• 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: 06/01/2020
• Supplement Report FDA Received Date: 07/13/2020
• 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: CATHETER,THERAPY DATE UNKNOWN