MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9968
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd maxguard administration set with needleless y-site(s) was missing a component.The following information was received by the initial reporter with the following verbatim.The customer sent in samples with two different lot numbers: if they are reporting only 1 lot number, the other lot number (23069048) will need a new complaint because that sample does not have a clamp as well.The new complaint will need to created, with the awareness date of (b)(6) 2023, the day i was able to verify that material mx9968, lot number 23069048 was missing its roller clamp.
Additional Manufacturer Narrative
It was reported by the customer that the tubing was missing the roller clamps.One sample of material number mx9968, lot number 23069048 was submitted for quality investigation.The customer complaint of clamp issues - missing roller clamps was verified by visual inspection.The samples submitted were visually examined and compared to the build of material of the infusion set.It was determined that both infusion sets were missing the roller clamp of the assembly.The investigation was forwarded to the manufacturing location for further evaluation.During investigation it was determined that the possible root cause for the issue was that the assembly instructions were not followed correctly.Additionally, analysis of the assembly method identified an excessive load in the operation where the roller clamp is inserted into the tubing, which can promote component skipping.Corrective action has been taken to rebalance the assembly operations.A device history record review for model mx9968 lot number 23069048 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09jun2023.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.
Event or Problem Description
No additional information was provided.Material#: mx9968, batch number#: 23069048.It was reported by customer that tubing were missing the roller clamps.Verbatim#: the customer sent in samples with two different lot numbers: if they are reporting only 1 lot number, the other lot number (23069048) will need a new complaint because that sample does not have a clamp as well.The new complaint will need to created, with the awareness date of 29oct2023, the day i was able to verify that material mx9968, lot number 23069048 was missing its roller clamp.

• Brand Name: BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S)
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18218792
• Report Number: 9616066-2023-02282
• Device Sequence Number: 14877335
• Product Code: FPA
• UDI-Device Identifier: 50885403237803
• UDI-Public: (01)50885403237803
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (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): 01/03/2024

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: 06/09/2026
• Device Catalogue Number: MX9968
• Device Lot Number: 23069048
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown