MAUDE Adverse Event Report: BECTON DICKINSON 32" GRAV SET W/0.2 MICRON FILTER TEXIUM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	4030B-07T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 4030b-07t batch # unknown.It was reported by customer that there was leakage from the texium male luer.Verbatim: there was leakage from the texium male luer.Bd texium items: ref 4030b-07t, 24601-b007t, 10013364t, 24301-0007t, my8030, my8020, my8060.Because the lot and expiration information is on the packaging material this information could not be easily tracked as those materials were discarded before the product was used and the leak issue detected.For pharmacy dates were not recorded.The issue first arose in july-august with some one-off occurrences that gradually escalated to almost daily occurrences by october when the issue was reported to bd.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
The customer reportedly returned samples with one of our sales reps, but unfortunately there was issues in the return process and the samples were not able to be returned to the lab for investigation.The customer complaint of texium leakage could not be verified due to the product not being returned for failure investigation.Although we could not confirm the reported failure, a trend has been identified and actions have been initiated to investigate the texium leakage issue.Corrective actions taken during this investigation will be implemented in our production process to further increase the robustness and reliability of the device and prevent future occurrences of this type.A device history record review could not be performed because the lot number is unknown.

• Brand Name: 32" GRAV SET W/0.2 MICRON FILTER TEXIUM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20853485
• Report Number: 9616066-2024-01866
• Device Sequence Number: 3838722
• Product Code: FPA
• UDI-Device Identifier: 10885403240867
• UDI-Public: (01)10885403240867
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 03/31/2025

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: Health Professional
• Device Catalogue Number: 4030B-07T
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown