MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BAG ACCESS DEVICE W/CKV; INTRAVASCULAR ADMINISTRATION SET

Model Number	2309E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a complaint of a damaged component was received from the customer.Two samples were provided for investigation.Through visual inspection, one sample had a misassembled check valve, the other did not have any noticeable defects.The two samples were then primed.The misassembled sample could not be primed due to fluid not being able to flow through set.The other sample was successfully primed.A device history record review for model 2309e lot number 20076260 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.Root cause description: the root cause for this defect is an error during the assembly process of the set.
Event or Problem Description
It was reported that bag access device w/ckv was occluded.The following information was provided by the initial reporter: material #: 2309e batch/ lot #: 20076260 ((b)(4) provided but invalid).It was reported that once the iv bag is spiked with the smartsite bag access device, the nurse cannot pull back fluid from the bag.

• Brand Name: BAG ACCESS DEVICE W/CKV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 11143927
• Report Number: 9616066-2020-20743
• Device Sequence Number: 3950175
• Product Code: FPA
• UDI-Device Identifier: 37613203011663
• UDI-Public: 37613203011663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: 07/25/2023
• Device Model Number: 2309E
• Device Catalogue Number: 2309E
• Device Lot Number: 20076260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1