MAUDE Adverse Event Report: CAREFUSION EXT SET SMALLBORE TBG W/4 FEMALE LL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10015817
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 ext set smallbore tbg w/4 female ll tubing leaked.The following information was provided by the initial reporter: material no.: 10015817.Batch no.: unknown.It was reported that the tubing leaked at the connection of a quad-fuse and the tpn filter at 2:00pm.Brief description: leaking connections on 2 different gtt lines.Line was changed at 1000 for leaking line.Line changed again at 1400 for line leaking again.Both lines were let up with quad-fuse tubing.1st line was leaking at the connection of the quad-fuse and a microbore tubing.2nd line was leaking at the connection of a quad-fuse and the tpn filter.Both quad-fuses saved.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 07/08/2020.Investigation conclusion: the customer reported ¿the tubing leaked at the connection of a quad-fuse and the tpn filter at 2:00pm¿.Received from the customer was one used extension set model 10015817 lot unknown.Attached to each of the set¿s four female luers was a male luer with approximately five inches of severed tubing from an unknown set.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Traces of clear liquid was observed in the set¿s tubing.No other abnormalities were observed on the set during visual inspection.To prepare the set for functional testing a lab microbore filter extension set was attached to the set¿s male luer.An 18 gauge lab cannula was attached to the end of the lab extension set.The received attached partial severed sets were first verified that their male luers were securely attached to the set¿s four female luers connectors, then removed and a lab microbore extension set was attached to each of the female luers.Functional testing was performed by attaching a lab 10ml bd syringe filled with blue-dyed water to each of the lab extension sets and depressing the plunger.No leaking was observed at any of the connection sites, components, or tubing on the set.The set was pressure tested while submerged underwater with the fluid still contained within the set at 30 psi.A lab stopcock was attached to the lab extension set¿s male luer.No fluid or air bubbles were noted to be leaking at any of the connection sites, components, or tubing on the set.The set¿s female and male luer components were inspected under a microscope to determine if any damage was noted.No damage was observed on the components during visual inspection.The received male luers with severed tubing were also inspected under a microscope with no damage observed.Equipment used (visual inspection and testing performed on 14-sep-20).Air pressure regulator with pressure gauge, eq00151, calibration due date: 07-nov-20.Dino lite microscope, eq106199, ncr.Optical ram-cnc, eq08204, calibration due date: 05-feb-21.The device history record for extension set model 10015817 lot unknown could not be conducted because the lot information was not provided.The root cause of the customer¿s report of leaking was not identified as we were unable to replicate the event during functional testing.H3 other text : see h10.
Event or Problem Description
It was reported that ext set smallbore tbg w/4 female ll tubing leaked.The following information was provided by the initial reporter: material no.: 10015817, batch no.: unknown.It was reported that the tubing leaked at the connection of a quad-fuse and the tpn filter at 2:00pm.Brief description: leaking connections on 2 different gtt lines.Line was changed at 1000 for leaking line.Line changed again at 1400 for line leaking again.Both lines were let up with quad-fuse tubing.1st line was leaking at the connection of the quad-fuse and a microbore tubing.2nd line was leaking at the connection of a quad-fuse and the tpn filter.Both quad-fuses saved.

• Brand Name: EXT SET SMALLBORE TBG W/4 FEMALE LL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10317138
• Report Number: 9616066-2020-02204
• Device Sequence Number: 2525772
• Product Code: FPA
• UDI-Device Identifier: 10885403234057
• UDI-Public: 10885403234057
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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 Model Number: 10015817
• Device Catalogue Number: 10015817
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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: 20200628; 20200628
• Outcome Attributed to Adverse Event: Other