MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SECONDARY BLOOD SETS - SET, BLOOD, SECONDARY, W/200 MIC FILT; INTRAVASCULAR ADMINISTRATION SET

Model Number	10014081
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd secondary blood sets - set, blood, secondary, w/200 mic filt experienced assembled incorrectly.The following information was provided by the initial reporter: he nurse was about to hang a blood product with secondary blood tubing.She removed the blood tubing from the package and noticed the filter was manufactured "upside down".
Additional Manufacturer Narrative
The initial reporter also notified the fda on (b)(6) 2022.Medwatch report # 2100090000-2022-8007.Investigation summary: a complaint of the filter being assembled upside down was received from the customer.Two photos were provided for investigation.In the photos the packaging can be seen as well as the material and lot information.A device history record review for model: 10014081 lot number: 21089134 was performed.The search showed that a total of 7,003 units in 1 lot number was built on 31aug2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined as a physical sample was not returned for investigation.Possible root cause is an error during the assembly process.This incident has been added to our database of reported incidents.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 08-jul-2022.H6: investigation summary : a complaint of the filter being assembled upside down was received from the customer.A sample was returned for investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample indicates that the drip chamber of the assembly was constructed in a manner that it would be upside down when connected.The tubing from the spike leads directly to the bottom port of the drip chamber.A device history record review for model 10014081 lot number 21089134 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31aug2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this defect is an error during the manufacturing process.H3 other text : see h10.
Event or Problem Description
It was reported that the bd secondary blood sets - set, blood, secondary, w/200 mic filt experienced assembled incorrectly.The following information was provided by the initial reporter: he nurse was about to hang a blood product with secondary blood tubing.She removed the blood tubing from the package and noticed the filter was manufactured "upside down".

• Brand Name: BD SECONDARY BLOOD SETS - SET, BLOOD, SECONDARY, W/200 MIC FILT
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14756144
• Report Number: 9616066-2022-00746
• Device Sequence Number: 16467343
• Product Code: FPA
• UDI-Device Identifier: 50885403233843
• UDI-Public: 50885403233843
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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: 08/31/2024
• Device Model Number: 10014081
• Device Catalogue Number: 10014081
• Device Lot Number: 21089134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown