MAUDE Adverse Event Report: CAREFUSION 17 INCH EXT W/.2 FLTR & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number 20028E

Device Problem Leak/Splash (1354)

Patient Problem Hypoglycemia (1912)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of the filter cracking and leaking could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 20028e because an invalid lot number was provided by the customer.Root cause analysis: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 17 inch ext w/.2 fltr & vlv port was cracked and leaked.The baby had low blood sugar.The following information was provided by the initial reporter: material no: 20028e batch no: h37020028e19.It was reported smart site extension filter cracked with leakage; baby had low blood sugar and clotted picc line.Customer 07 aug 2020: it looks like all of our omni cells are stocked with the same lot #.This defect has caused some significant issues with 2 of our babies.One ended up needed a surgical line placed after her picc line clotted off.

• Brand Name: 17 INCH EXT W/.2 FLTR & VLV PORT
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 s state st; sandy UT 84070 3213
• Manufacturer Contact: brett wilko ; 9450 s state st; sandy, UT 84070-3213 ; 8015652341
• MDR Report Key: 10456972
• MDR Text Key: 204531455
• Report Number: 9616066-2020-02578
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: 7613203012393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention