MAUDE Adverse Event Report: CAREFUSION 60 IN ULTRA MINIBORE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number ME2017

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem Underdose (2542)

Event Date 04/16/2020

Event Type  malfunction  

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 Description

It was reported that 60 in ultra minibore extension set leaked and the patient did not receive full dose of medication.The following information was provided by the initial reporter: material no.: me2017, batch no.: unknown.It was reported by the customer that the line appeared to be leaking where the line connects to the syringe.Additional info rcvd: upon first assessment, pt's dexmedetomidine line appeared to be leaking where the line connects to the syringe.Upon further inspection, there was a moderate sized puddle next to the bed which was clearly dexmedetomidine and the patient was reported to have been very uncomfortable all night and was visibly agitated upon first assessment.Appears that pt did not receive full dose of medication for several hours.Line was tightly connected to syringe but still leaking.Syringe and line replaced and saved.Pt resting comfortably at the time of this note.

Manufacturer Narrative

The following fields have been updated with additional information: a.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.A.2.Age at time of event: 3.A.2.Age units (patient): years.A.3.Sex: male.H.3.Device evaluated by mfg?: yes.H.3.Reason device not evaluated: other h.3.Reason device not eval: see h.10.H.6.Investigation summary: it was reported by the customer that the line appeared to be leaking where the line connects to the syringe.Received from the customer is one used extension set model me2017 lot unknown.Set was received with traces of medication in the tubing.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found a crack in the female luer wall (p/n 1024-085-043).No tool marks or signs of over torque were observed.A lab syringe filled with blue dye water was attached to the set for a priming test.The set leaked from the cracked female luer.No leaks were observed anywhere else throughout the set.The female luer cavity number is 54b.Device history record for model me2017 could not be performed due to no lot number being provided by customer.Root cause analysis: the customer¿s report of a leak where the line connects to the syringe was confirmed to be a female luer crack.The root cause of the luer damage could not be definitively determined.Investigation conclusion: the customer¿s report of a leak where the line connects to the syringe was confirmed to be a female luer crack.Visual inspection found that the female luer had a lateral crack.Closer inspection under a lab microscope observed no tool marks or signs of over torque.Previous investigations have shown that stress and cracks may result from overtightening on the female luer.In addition, previous similar investigations have found that if the application of alcohol was not allowed proper time to dry when mating components, it could create a bond resulting in difficulties during disconnection.

Event Description

It was reported that 60 in ultra minibore extension set leaked and the patient did not receive full dose of medication.The following information was provided by the initial reporter: material no.: me2017 batch no.: unknown.It was reported by the customer that the line appeared to be leaking where the line connects to the syringe.Additional info rcvd: upon first assessment, pt's dexmedetomidine line appeared to be leaking where the line connects to the syringe.Upon further inspection, there was a moderate sized puddle next to the bed which was clearly dexmedetomidine and the patient was reported to have been very uncomfortable all night and was visibly agitated upon first assessment.Appears that pt did not receive full dose of medication for several hours.Line was tightly connected to syringe but still leaking.Syringe and line replaced and saved.Pt resting comfortably at the time of this note.

• Brand Name: 60 IN ULTRA MINIBORE EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10193091
• MDR Text Key: 196995777
• Report Number: 9616066-2020-02004
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236242
• UDI-Public: 10885403236242
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ME2017
• Device Catalogue Number: ME2017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200416
• Patient Outcome(s): Other
• Patient Age: 3 YR