MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. LGE BORE Y EXT W/VP 3 SL CL; INTRAVASCULAR ADMINISTRATION SET

Model Number	20061E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a complaint of set 20061e being the incorrect length was received from the customer.92 samples were returned for investigation.Through visual inspection no defects were observed.All samples were measured to confirm that they were within the specified length requirements.All sets were within within specification.A device history record review for model 20061e lot number 20096296 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as the samples were within specifications.Root cause description: due to the samples being within specification a root cause could not be determined.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.
Event or Problem Description
It was reported that 100 lge bore y ext w/vp 3 sl cl sets had defective tubing that were shorter than the advertised "7 inches in length".The following information was provided by the initial reporter: "received product but online diagram of product seems to be misleading as the tubing needs to be longer.The tubing is under 7 inches in length.".

• Brand Name: LGE BORE Y EXT W/VP 3 SL CL
• 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: 11269618
• Report Number: 9616066-2021-50151
• Device Sequence Number: 14295713
• Product Code: FPA
• UDI-Device Identifier: 37613203011885
• UDI-Public: 37613203011885
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/19/2021

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: 09/22/2023
• Device Model Number: 20061E
• Device Catalogue Number: 20061E
• Device Lot Number: 20096296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• 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