MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE GRAVITY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	42133E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 that bd alaris smartsite gravity set needle inside the drip chamber is missing.The following information was provided by the initial reporter: we have had several of these *** that are missing the needle inside the tube.Response received on (b)(6) -2023.¿ are you able to advise the date of event? (b)(6) 2023, (b)(6) 2023 plus other days that was not reported to me.¿ what is the total quantity of affected tubing? - over 20.¿ is there sample available to return for investigation? - yes.¿ was the issue noticed when the product was taken out of package? yes - iv tubing was flowing to fast and was found to be defective.¿ was there any patient involvement? - yes.¿ if yes, was there any adverse event or serious injury reported? no response received on (b)(6) 2023.¿ were any of the events identified during priming of the tubing? - yes, the third occurrence.¿ were any of the defective tubing used on patients? - yes.¿ please describe what the patient involvement was.- the tubing was used on two pediatric patients that were having dental surgery.The tubing was changed out after the surgery was started on both cases.One case the surgery was almost done and the second case was about halfway done.¿ for which occurrence(s) did the patient involvement take place? - the first two occurrences ¿ a missing needle in the drip chamber would not allow for adequate rate circulation.If used on the patient, was the tubing replaced? was rate calculated in a different way? please describe.- the rate was done by anesthesia via free flow, the tubing was changed after the start of the cases and anesthesia noticed that the rate was flowing faster than normal.
Event or Problem Description
No additional information was provided.Material#: 42133e.Batch#: 23019320.It was reported by the customer that they have had several of these 42133e that are missing the needle inside the tube.Verbatim: customer reported have had several of these 42133e that are missing the needle inside the tube.Response received on 14-sep-2023.Are you able to advise the date of event? (b)(6) 2023.Plus other days that was not reported to me.What is the total quantity of affected tubing? - over 20.Is there sample available to return for investigation? - yes.Was the issue noticed when the product was taken out of package? yes - iv tubing was flowing to fast and was found to be defective.Was there any patient involvement? - yes.If yes, was there any adverse event or serious injury reported? no.Response received on 18-sep-2023.Were any of the events identified during priming of the tubing? - yes, the third occurrence.Were any of the defective tubing used on patients? - yes.Please describe what the patient involvement was.- the tubing was used on two pediatric patients that were having dental surgery.The tubing was changed out after the surgery was started on both cases.One case the surgery was almost done and the second case was about halfway done.For which occurrence(s) did the patient involvement take place? - the first two occurrences.A missing needle in the drip chamber would not allow for adequate rate circulation.If used on the patient, was the tubing replaced? was rate calculated in a different way? please describe.- the rate was done by anesthesia via free flow, the tubing was changed after the start of the cases and anesthesia noticed that the rate was flowing faster than normal.
Additional Manufacturer Narrative
Three photos and ten samples of item#42133e were submitted for quality investigation.Nine samples of lot# 23019320, and one sample of lot number 23019319, were submitted for quality investigation.The customer complaint of misassembly, was confirmed from the photos submitted and the nine samples with lot #23019320.The sample of lot # 23019319 was not missing the drip chamber needle and was assembled correctly.Further examination of the samples does not indicate any mishandling or abuse of the samples that would cause the drip chamber needles to be removed from the infusion sets.Additionally, the drip chambers are sealed and there is no evidence that the needles are within the drip chamber body.The root cause for the failure identified in this investigation is a misassembly during the assembly of the infusion set.Investigation at the manufacturing location indicates that the assembly line clearing procedure was not followed correctly.An incorrect part was installed in the assembly due to not removing all of the previous assembly components from the assembly line.A quality alert was created to reinforce the correct line clearance procedure and assortment of materials on the production line.A device history record review for model 42133e lot number 23019320 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.

• Brand Name: BD ALARIS SMARTSITE GRAVITY SET
• 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 ; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 17814692
• Report Number: 9616066-2023-01953
• Device Sequence Number: 19452977
• Product Code: FPA
• UDI-Device Identifier: 37613203020924
• UDI-Public: (01)37613203020924
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: Health Professional
• Device Expiration Date: 01/22/2026
• Device Catalogue Number: 42133E
• Device Lot Number: 23019320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2023
• 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