MAUDE Adverse Event Report: CAREFUSION 3-PORT MANIFOLD W/EXT SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	20519E
Medical Device Problem Codes	Complete Blockage (1094); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 3-port manifold w/ext set malfunctioned on 134 occasions.The following information was provided by the initial reporter: material no: 20519e batch(lot) no: unknown.It was reported from anesthesia that several extension tubing sets were found to have the distal port facing the wrong direction.There was no patient involvement.It was brought to my attention today that the same lot # for the bd smartsite extension set with the 3 port manifold that is used for anesthesia medications has a defect with some of the supply.The distal port is facing the wrong direction which makes the medication go up the line instead of down and into the patient¿s system.
Event or Problem Description
It was reported that 3-port manifold w/ext set malfunctioned on 139 occasions.The following information was provided by the initial reporter: material no: 20519e batch(lot) no: 20016722.It was reported from anesthesia that several extension tubing sets were found to have the distal port facing the wrong direction.There was no patient involvement.It was brought to my attention today that the same lot # for the bd smartsite extension set with the 3 port manifold that is used for anesthesia medications has a defect with some of the supply.The distal port is facing the wrong direction which makes the medication go up the line instead of down and into the patient¿s system.
Additional Manufacturer Narrative
The following fields were updated due to additional information/corrections: b.5.Describe event or problem: it was reported that 3-port manifold w/ext set malfunctioned on 139 occasions.The following information was provided by the initial reporter: material no: 20519e batch(lot) no: 20016722 it was reported from anesthesia that several extension tubing sets were found to have the distal port facing the wrong direction.There was no patient involvement.It was brought to my attention today that the same lot # for the bd smartsite extension set with the 3 port manifold that is used for anesthesia medications has a defect with some of the supply.The distal port is facing the wrong direction which makes the medication go up the line instead of down and into the patient¿s system.D.4.Medical device lot #: 20016722.D.4.Medical device expiration date: 2023-01-20.H.4.Device manufacture date: 2020-01-20.D.10 device available for eval yes.D.10 returned to manufacturer on: 09/03/2020.Investigation conclusion a complaint of disassembly was received from the customer.Samples were sent in for investigation, and from these samples the complaint of disassembly could not be verified.Visual evaluation of the samples was performed with the assembly drawing.A device history record review for model 20519e lot number 20016722 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20jan2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be established due to the issue not being verified.

• Brand Name: 3-PORT MANIFOLD W/EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10486374
• Report Number: 9616066-2020-02630
• Device Sequence Number: 4060396
• Product Code: FPA
• UDI-Device Identifier: 10885403234941
• UDI-Public: 10885403234941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 01/20/2023
• Device Model Number: 20519E
• Device Catalogue Number: 20519E
• Device Lot Number: 20016722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other