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	07/28/2020
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: 1901718.It was reported that patient noticed leaking from filter and stated this happened 3 times.Event description: during infusion of daratumumab study drug pt noticed leaking coming from filter; infusion stopped; ids pharmacy called and filter replaced - site cleaned with soap and water; infusion resumed with new filter; pt stated this is 3rd incident.
Additional Manufacturer Narrative
Due to no photo or sample being received, the customer's complaint of leakage could not be verified.A device history record review for model mx9166 lot number 19017181 was performed.The search showed that a total of (b)(6) in 1 lot number was built on 30jan2019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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: 19017181 it was reported that patient noticed leaking from filter and stated this happened 3 times.Event description: during infusion of daratumumab study drug pt noticed leaking coming from filter; infusion stopped; ids pharmacy called and filter replaced - site cleaned with soap and water; infusion resumed with new filter; pt stated this is 3rd incident.

• 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: 10570911
• Report Number: 9616066-2020-02734
• Device Sequence Number: 2992268
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Other
• Device Expiration Date: 01/30/2024
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 19017181
• 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: 10/22/2020
• 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: 20200728; 20200728
• Outcome Attributed to Adverse Event: Other