MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10 INCH EXT W/ 0.2 PED & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20029E
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	01/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: one sample was returned by the customer.Sample was connected to a bd syringe and attempted to flush water through the set.Set was unable to be primed.The set was analyzed under higher magnification.Excess solvent was seen between the female luer and the tubing.A device history record review for model 20029e lot number 20065870 was performed.The search showed that a total of 4103 units in 1 lot number was built on 15jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: the customer complaint that a smartsite extension set occluded with infusion was verified.Root cause description: the root cause of the occlusion was due to the excess solvent.Rationale: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
Event or Problem Description
It was reported that the 10 inch  ext w/ 0.2 ped & vlv port was occluded during the infusion.The following information was provided by the initial reporter: "we have a bd smartsite extension set that occluded with infusion.".

• Brand Name: 10 INCH EXT W/ 0.2 PED & VLV PORT
• 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: 11270426
• Report Number: 9616066-2021-50156
• Device Sequence Number: 12011336
• Product Code: FPA
• UDI-Device Identifier: 50885403234864
• UDI-Public: 50885403234864
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 01/21/2021

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: 06/13/2023
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Device Lot Number: 20065870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1