MAUDE Adverse Event Report: CAREFUSION SD BAG ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number	2300E-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: the customer provided lot # 2004488 and 200438a.These do not match the catalog number provided.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown, medical device lot #: 20025450, medical device expiration date: 2023-02-14, device manufacture date: 2020-02-05.Investigation summary: no product or photo was returned by the customer.It was reported that the spike was snapping off at the point of the clear luer lock mechanism.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 2300e-0500 lot number 20025450 was performed.The search showed that a total of 12,003 units in 1 lot number was built on 17feb2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 or Problem Description
It was reported that bag access device spike was broken.The following information was provided by the initial reporter: material no.: 2300e-0500, batch no.: 20025450, unknown (provided: 200438a, 2004488).It was reported the spike is snapping off at the point of the clear luer lock mechanism.

• Brand Name: BAG ACCESS DEVICE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10570916
• Report Number: 9616066-2020-02759
• Device Sequence Number: 2992893
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: 10885403235023
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• 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
• 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 Model Number: 2300E-0500
• Device Catalogue Number: 2300E-0500
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other