MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9279
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector leaked from the valve during use.The following information was provided by the initial reporter, translated from french: "leak at the valve level despite well connected tubing and despite changed tubing (it is the valve where the parenteral nutrition passed).".
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector leaked from the valve during use.The following information was provided by the initial reporter, translated from french: "leak at the valve level despite well connected tubing and despite changed tubing (it's the valve where the parenteral nutrition passed)".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 02-may-2023.One mz9279 sample was received without the original packaging for investigation; residual fluid was present in the device.On this occasion, the lot number of the complaint product was reported unknown.The feedback provided by the customer suggests leakage was detected from the maxzero extension set approximately 4 hours into the infusion.The customer also confirmed the connecting product was a braun infusion set.Functional testing was performed by connecting the returned sample to a 50ml bd plastipak syringe from stock and attempting to prime with fluid, in this instance the customer's experience was confirmed as leakage was detected from the maxzero female luer adaptor (fla).A close inspection of the location of the leakage revealed the maxzero fla to be cracked.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.Although a definitive root cause could not be determined in this instance, previous investigations have confirmed similar damage can be caused or contributed to by a combination of different factors, including prolonged use of substances that are aggressive to plastics, over-torque of the component during connection with the male luer, or use of a male luer that is not compliant to iso standards.H3 other text : see h10.

• Brand Name: BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16328021
• Report Number: 9616066-2023-00164
• Device Sequence Number: 20978205
• Product Code: FPA
• UDI-Device Identifier: 10885403230622
• UDI-Public: 10885403230622
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: MZ9279
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown