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

Catalog Number	MPXT5302-C
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd extension set was disconnecting.The following information was received by the initial reporter with the following verbatim: customer noted: we are having an issue where a piece of this iv tubing keeps breaking and coming apart.Huge issue, not only with contamination, but if it falls apart when connected to a patient and the arms are out of our reach/visualization in surgery, it can lead to exsanguination.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported the t-connector separates easily and returned 254 samples.Of the 254, 250 were unopened in shelf cartons, 4 were opened already.Lot# 24039245-qty (b)(4), 24059092-qty (b)(4).The samples were tested and the failure mode of luer collar on the t-connector easily separating was confirmed.The samples were examined under a microscope, and the lip on the male luer that retains the luer collar was found to be out of specification.This lip was too small, allowing the collar to loosely slide off the luer.The t-connector (b)(6) dimension was found to be out of specification [spec is 0.254 +-.002''].Device history record review for model mpxt5302-c lot number 24039245 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13mar2024.Device history record review for model mpxt5302-c lot number 24059092 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05may2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This issue has been escalated into a funded project at the manufacturing site to address and mitigate the risk of this issue recurring.This project includes a work order to replace the slide core pin for the mold m438, a quality notification to contain lots in process, and a quality alert to communicate to personnel the issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD 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: 20150436
• Report Number: 9616066-2024-01255
• Device Sequence Number: 12826864
• Product Code: FPA
• UDI-Device Identifier: 10885403274657
• UDI-Public: (01)10885403274657
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• 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): 12/09/2024

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: MPXT5302-C
• Device Lot Number: 24039245
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown