MAUDE Adverse Event Report: CAREFUSION AS LVP 10D 3SS 2CV; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2452-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that as lvp 10d 3ss 2cv leaked.The following information was provided by the initial reporter: material #: 2452-0007, batch #: 19107100.It was reported a leakage.
Additional Manufacturer Narrative
Received from the customer was one used primary set model 2452-0007 lot 19107100 with its original package.A note attached to the package reads: ¿defective tubing ¿ leak¿.A second empty original package was received for set model 2452-0007 lot 19115322.A note attached to this package reads: ¿tubing broken at distal connection¿.Received was a copy of the customer¿s ¿product investigation¿ form.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.A vertical tear on the tubing (p/n 620-00065) measuring approximately 0.0970 inches long was observed twenty one inches below the lower fitment.Clear liquid was observed in the set¿s drip chamber and entire length of tubing.No other abnormalities were observed with the set.Although damage was observed, functional testing was performed by filling a lab iv bag with blue-dyed water and attaching the returned used disposable set allowing fluid to flow through the set via gravity.Blue-dyed water was observed to be dripping out of the location of the tear in the tubing.Equipment used (visual inspection and measurement performed on (b)(6)-20) - calipers, eq02784, calibration due date: 19-dec-20 - optical ram-cnc, eq08204, calibration due date: 05-feb-21 - dino lite microscope, eq106199, ncr the device history record for primary set model 2452-0007 lot 19107100 was performed.The search showed a total of (b)(4) in 1 lot were built on 29 october 2019.There were no related qn¿s (quality notifications) issued during the production build of this set for the failure mode reported for the given time frame.The leaking was determined to be due to a tear in the set¿s tubing below the lower fitment.Manufacturing facility (tijuana) has been made aware of this type of reported issue; corrective actions (capa 723603) was completed to address the root causes that are specific to their manufacturing site and has an effectiveness check plan for reduction of issue.The investigation was not able to find a definitive root cause but confirmed multiple proximate causes that can occur during the various steps of the manufacturing and shipping processes.H3 other text : see h10.
Event or Problem Description
It was reported that as lvp 10d 3ss 2cv leaked.The following information was provided by the initial reporter: material #: 2452-0007 batch #: 19107100 it was reported a leakage.

• Brand Name: AS LVP 10D 3SS 2CV
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10238951
• Report Number: 9616066-2020-02053
• Device Sequence Number: 2485252
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: Other
• Device Expiration Date: 10/29/2022
• Device Model Number: 2452-0007
• Device Catalogue Number: 2452-0007
• Device Lot Number: 19107100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 09/15/2020
• 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: 20200610; 20200610
• Outcome Attributed to Adverse Event: Other