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

Catalog Number MZ1000

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported when using the bd maxzero¿ needleless connector there were leaks.The following information was provided by the initial reporter.The customer stated: "blood leakage from the connector was observed.".

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd maxzero¿ needleless connector there were leaks.The following information was provided by the initial reporter.The customer stated: "blood leakage from the connector was observed.".

Event Description

It was reported when using the bd maxzero¿ needleless connector there were leaks.The following information was provided by the initial reporter.The customer stated: "blood leakage from the connector was observed.".

Manufacturer Narrative

H.6.Investigation: one mz1000 sample was received for investigation without packaging, however the lot number was indicated as 21015542.No connecting products were received to assist the investigation in this instance.The sample was subjected to pressure testing in order to replicate the customer's experience; leakage was observed from a crack to the female luer adaptor of the maxzero.The details of this feedback were forwarded to the manufacturing site for investigation.Previous investigations have been unable to determine a potential root cause for the customer's experience; no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed damage.Dhr was performed and no qn's were found.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.In this instance based on the information available, it is not possible to determine which of these factors may have contributed to the customer's experience.H3 other text : see h.10.

• Brand Name: BD MAXZERO¿ NEEDLELESS CONNECTOR
• Type of Device: 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: 13114668
• MDR Text Key: 286116897
• Report Number: 9616066-2021-52659
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/13/2024
• Device Catalogue Number: MZ1000
• Device Lot Number: 21015542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1