MAUDE Adverse Event Report: CAREFUSION SD 16 IN NON-DEHP STND BORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9166
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
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 16 in non-dehp stnd bore extension set leaked.The following information was provided by the initial reporter: material no: mx9166.Batch no: 20025076.Event description: maxguard extension set with 0.2 micron filter and needless y-site leaked when connect to chemotherapy.I did not witness leak myself.However, the rn stated this has happened previously so packaging was saved.
Event or Problem Description
It was reported that 16 in non-dehp stnd bore extension set leaked.The following information was provided by the initial reporter: material no: mx9166 batch no: 20025076.Event description: maxguard extension set with 0.2 micron filter and needless y-site leaked when connect to chemotherapy.I did not witness leak myself.However, the rn stated this has happened previously so packaging was saved.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of leaking at the y-port could not be verified due to the product not being returned for failure investigation.The root cause of this failure was not identified as no product was returned.A device history record review for model mx9166 lot number 20025076 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05feb2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: 16 IN NON-DEHP STND BORE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10570915
• Report Number: 9616066-2020-02732
• Device Sequence Number: 2992271
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• PMA/510(K) Number: K051499
• 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): 09/02/2020

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: Health Professional
• Device Expiration Date: 02/24/2025
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 20025076
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/05/2020
• 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: 20200714; 20200714
• Outcome Attributed to Adverse Event: Other