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

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2023

Event Type  malfunction  

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 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.

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 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)
• Type of Device: 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
• MDR Text Key: 329144496
• Report Number: 9616066-2023-02282
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403237803
• UDI-Public: (01)50885403237803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: MX9968
• Device Lot Number: 23069048
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1