MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD GRAV BLD SET 200MF 20 DP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10387509
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd grav bld set 200mf 20 dp filter was inverted.The following was reported by the initial reporter with the verbatim: ¿bd gravity blood 200 micron filter nonvented¿ tubing in which the filter is inverted.Was the event discovered before use/during use? before use.Was there any patient involvement? no.If yes, what is the patient outcome? are there any adverse events/serious injuries? was there a delay of, or change in, the course of treatment due to the event? minimal delay, nurse just grabbed another set.What type of procedure is being performed? set had not been hooked up to prbc yet so no procedure.What was the medication/fluid in use at the time of the event? nothing, set had not been spiked.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary one sample was submitted for quality investigation.The customer complaint of misassembly - inverted component was verified by investigation.Evaluation of the sample submitted shows that the drip chamber was installed backwards in the assembly.A device history record review for model 10387509 lot number 22099074 was performed.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 the misassembly was that the proper sequence of operations, outlined in the work instruction was not followed and the incorrect sides of the drip chamber were assembled first, therefore causing the drip chamber to be inverted in the complete assembly.A quality alert was created in order to reinforce the adequate monitoring of the operations that make up the assembly process to avoid the failure mode on future production.
Event or Problem Description
It was reported that bd grav bld set 200mf 20 dp filter was inverted.The following was reported by the initial reporter with the verbatim: ¿bd gravity blood 200 micron filter nonvented¿ tubing in which the filter is inverted.- was the event discovered before use/during use? before use - was there any patient involvement? no - if yes, what is the patient outcome? are there any adverse events/serious injuries? - was there a delay of, or change in, the course of treatment due to the event? minimal delay, nurse just grabbed another set.- what type of procedure is being performed? set had not been hooked up to prbc yet so no procedure.- what was the medication/fluid in use at the time of the event? nothing, set had not been spiked.

• Brand Name: BD GRAV BLD SET 200MF 20 DP
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17573710
• Report Number: 9616066-2023-01773
• Device Sequence Number: 9006341
• Product Code: FPA
• UDI-Device Identifier: 50885403234215
• UDI-Public: (01)50885403234215
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: 09/05/2025
• Device Catalogue Number: 10387509
• Device Lot Number: 22099074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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