MAUDE Adverse Event Report: BECTON DICKINSON MICROBORE TRI-FUSE EXTENSION SET, 3 IV.C; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ9270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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#: mz9270 batch number#: unknown it was reported by customer that bd maxzero microbore tri-fuse extension set was added to a central line, no issues noted when priming.However, a couple of hours later the sheet on the bed was noted to be damp and upon further inspection the filtered lumen of the tri-fuse set was leaking.This was replaced with a new extension and the leak was confirmed with flushing the filtered lumen.This leak was where the plastic filter attaches to the tubing on the side of the filter that is proximal to the patient.Verbatim#: rcc received a complaint via email.Product name set ext micbor trifus 3iv 4clm.Manufacturer bd.Catalog # mz9270.Item # 614617.Issue description bd maxzero microbore tri-fuse extension set was added to a central line, no issues noted when priming.However, a couple of hours later the sheet on the bed was noted to be damp and upon further inspection the filtered lumen of the tri-fuse set was leaking.This was replaced with a new extension and the leak was confirmed with flushing the filtered lumen.This leak was where the plastic filter attaches to the tubing on the side of the filter that is proximal to the patient.
Event or Problem Description
Material#: mz9270 batch number#: unknown (24069402).It was reported by customer that bd maxzero microbore tri-fuse extension set was added to a central line, no issues noted when priming.However, a couple of hours later the sheet on the bed was noted to be damp and upon further inspection the filtered lumen of the tri-fuse set was leaking.This was replaced with a new extension and the leak was confirmed with flushing the filtered lumen.This leak was where the plastic filter attaches to the tubing on the side of the filter that is proximal to the patient.Verbatim#: rcc received a complaint via email.Product name set ext micbor trifus 3iv 4clm.Manufacturer bd.Catalog # mz9270.Item # 614617.Issue description bd maxzero microbore tri-fuse extension set was added to a central line, no issues noted when priming.However, a couple of hours later the sheet on the bed was noted to be damp and upon further inspection the filtered lumen of the tri-fuse set was leaking.This was replaced with a new extension and the leak was confirmed with flushing the filtered lumen.This leak was where the plastic filter attaches to the tubing on the side of the filter that is proximal to the patient.
Additional Manufacturer Narrative
The customer reported the tubing and filter were leaking, and returned one set of material mz9270, lot unknown.Upon initial visual examination, the set had no defects or abnormalities.The set was infused with water and the complaint was verified, leaking was found from the filter outlet port at the connection with tubing.The manufacturing is working on the root cause for the solvent issue through a funded project to ensure that the risk of recurrence is addressed.A quality alert was generated 07nov2024 to communicate the failure and reinforce the correct method of joining the components (tubing/pediatric filter).This issue is a high-priority for bd quality.

• Brand Name: MICROBORE TRI-FUSE EXTENSION SET, 3 IV.C
• 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: 20875012
• Report Number: 9616066-2024-01928
• Device Sequence Number: 15594716
• Product Code: FPA
• UDI-Device Identifier: 10885403240737
• UDI-Public: (01)10885403240737
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 12/19/2024

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: Health Professional
• Device Catalogue Number: MZ9270
• Device Lot Number: UNKNOWN
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown