MAUDE Adverse Event Report: BECTON DICKINSON 7 INCH MIC EXT SET W/1.2MF; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20129E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material # 20129e; batch # 24089016.It was reported by customer that 20129e, leaking at the lipid filter.
Additional Manufacturer Narrative
The customer reported a leaking lipid filter and returned one used sample of material 20129e, lot 24089016.Upon initial visual examination, the set had no defects or abnormalities.The set was infused with water and the leak was verified.The samples were then forwarded to the supplier of the filter.The supplier was able to put the filters through a process to reset the filter to status before any medications or infusions took place, and then re-tested.After this process, the filter no longer had a leak.The potential root cause is the drugs/solutions used in the filter.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Material # 20129e, batch # 24089016.It was reported by customer that 20129e, leaking at the lipid filter.Verbatim: rcc received a complaint via email.Email(s) attached.I have a defective tubing, item 20129e lot (10)24089016, leaking at the lipid filter, i have the product if you want me to send it to you.Additional information received on 15nov.1.Can you please provide an exact date of event in mm-dd-yyyy format? 11/12.2.What was the impact to the patient? tubing had to be changed and central line was potentially open to contamination.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details no.4.What was the medication/fluid in use at the time of the event? lipids 5.Was this a chemotherapy drug? no.

• Brand Name: 7 INCH MIC EXT SET W/1.2MF
• 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: 20854888
• Report Number: 9616066-2024-01880
• Device Sequence Number: 8776241
• Product Code: FPA
• UDI-Device Identifier: 10885403234903
• UDI-Public: (01)10885403234903(11)240801(17)270801(10)24089016
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 01/22/2025

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: 20129E
• Device Lot Number: 24089016
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown