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

Catalog Number	ME2010
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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: i¿m sorry to email again, but after asking around about this, nurses have told me that the main issue with this tubing is when unscrewing the end of the tubing from a patient¿s line, the spin collar un-luer locks from the patient¿s line, but leaves the small plastic end of the tubing in the patient¿s line (syringe tubing still attached).When this happens, the nurse doesn¿t have anything to grip on the tubing with, and then has to pull the syringe tubing taut and ¿yank¿ the syringe tubing free from the patient¿s line.I have had numerous nurses believe the tubing was broken because the spin collar at the end of the tubing ¿slides¿ freely and separately from the end where the tubing is to luer lock into something.On our previous tubing, the spin collar was fixed to the end of the tubing.
Additional Manufacturer Narrative
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 tubing becoming stuck in the ports/lines.One sample extension set, item me2010, and an unknown clear connector was submitted for quality investigation.Visual examination of the me2010 extension set did not indicate any damages to the construction, however, examination of the unknown connector indicates that a male luer that was connected to the unknown connector cracked inside the connector.Although we have identified a cracked luer inside the unknown clear connector, it cannot be determined if the cracked end came from a sample of me2010.The customer complaint of a connection issue with extension set me2010 could not be verified.The failure of a cracked luer on the sample of me2010 was not confirmed from the sample that was submitted, and therefore a root cause was not determined.A device history record review for model me2010 lot number 23129076 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05dec2023.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: 19038450
• Report Number: 9616066-2024-00521
• Device Sequence Number: 12580464
• Product Code: FPA
• UDI-Device Identifier: 10885403236235
• UDI-Public: (01)10885403236235
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 06/26/2024

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: ME2010
• Device Lot Number: 23129076
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown