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

Catalog Number	ME2068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxguard extension set was damaged.The following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.The cap/connector of tubing broke during a peripheral line connection requiring replacement with new tubing.
Additional Manufacturer Narrative
A2.Patient¿s birthday was not provided, (b)(6) was used based on age of patient e4.The initial reporter also notified the fda on 26 jun, 2024.Medwatch report # mw5156846 h.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that the cap/connector of tubing broke during a peripheral line connection requiring replacement with new tubing.One sample of item me2068 was submitted for quality investigation.Visual inspection of the sample indicates that the securement collar of the luer connector is missing.Further examination of the luer securement collar indicates that the collar was broken off.Under magnification, it can be seen that part of the securement collar is still attached to the connector, suggesting that the securement collar was intentionally broken off.The customer complaint of adapter / connector defective / damaged was verified.Further evaluation of the failure was conducted by manufacturing and our component quality teams.The manufacturing team indicated that the issue reported could not have happened during the assembly process.Additionally, the supplier quality team evaluated the failure and deemed that the failure was not due to the supplier quality.The root cause of the failure could not fully be determined.The probable cause for the damage seen in sample is that the securement collar of the luer was damaged during connection or disconnection.A device history record review for model me2068 lot number 22019197 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27jan2022.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.

• Brand Name: BD MAXGUARD EXTENSION 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20000491
• Report Number: 9616066-2024-01185
• Device Sequence Number: 14684774
• Product Code: FPA
• UDI-Device Identifier: 10885403236297
• UDI-Public: (01)10885403236297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Catalogue Number: ME2068
• Device Lot Number: 22019197
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Male