MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SEC 20DP NO PORTS W/HANGER DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	11582774
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd sec 20dp no ports w/hanger dehp free the components were separated.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the "tubing was not connected to chamber".Verbatim: event description: bedside rn opened secondary iv tubing set and noticed tubing was not connected to chamber.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd sec 20dp no ports w/hanger dehp free the components were separated.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the "tubing was not connected to chamber".Verbatim: event description: bedside rn opened secondary iv tubing set and noticed tubing was not connected to chamber.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-aug-2022.H6: investigation summary the customer reported a separation and returned one used 11582774.The sample was separated below the drip chamber, and the complaint is verified.The root cause was found to be traced to the assembly process.Manufacturing will review operations to mitigate the risk of this issue happening again.Device history record review for model 11582774 lot number 22049332 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 26apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD SEC 20DP NO PORTS W/HANGER DEHP FREE
• 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: 15316231
• Report Number: 9616066-2022-01237
• Device Sequence Number: 12043323
• Product Code: FPA
• UDI-Device Identifier: 50885403234758
• UDI-Public: 50885403234758
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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): 09/19/2022

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: Health Professional
• Device Expiration Date: 04/25/2025
• Device Model Number: 11582774
• Device Catalogue Number: 11582774
• Device Lot Number: 22049332
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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