MAUDE Adverse Event Report: BECTON DICKINSON PRESSURE RATED EXT SET, IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ5303
Medical Device Problem Code	Loose or Intermittent Connection (1371)
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
This is a complaint about the loose connection.When the customer used a max zero extension tube, they connected the male part of the extension tube from terumo to the female part of the max zero to adjust the length.There was no problem when they connected it, but after a while it became loose.
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.
Additional Manufacturer Narrative
Additional information in adverse event or prod prob (b).Investigation result: one mz5303 sample was received for investigation, in which the customer has stated: "when the customer used a max zero extension tube, they connected the male part of the extension tube from terumo to the female part of the max zero to adjust the length.There was no problem when they connected it, but after a while it became loose." no packaging was received with the sample and the customer did not provide a lot number with the feedback.The sample appears to be unused, as there is no residual fluid present in the line and the protective cap was still in place.A visual inspection of the returned sample did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing confirmed the connection between the maxzero and other bd stock products remained secure; no inadvertent disconnection occurred throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned sample did not identify any product defects or quality deviation that could have contributed to the customer¿s experience.In this instance, the connecting product used at the time of the loose connection was not returned to assist the investigation, therefore it is not possible to determine if this may have contributed to the customer's experience.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.Although it was not possible to determine a definitive root cause for the customer's experience, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mz5303 set in the past 12 months.
Event or Problem Description
Additional information: please confirm how the fault was identified? looseness was found by a nurse.Please confirm if there is any visible damage on the set ¿ such as cracks, flashes or deformation of the piston? no damage that can be visually confirmed.Please confirm if the loose connection led to any disconnection? not completely dislodged.

• Brand Name: PRESSURE RATED EXT SET, IV CONNECTOR
• 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: 20863547
• Report Number: 9616066-2024-01887
• Device Sequence Number: 8785906
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: (01)10885403230561
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: MZ5303
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown