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

Model Number MZ1000-07

Device Problem Obstruction of Flow (2423)

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

It was reported that during use with 5 bd maxzero¿ needleless connector there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: when connected with our maxzero, the pump indicated high pressure.This happens for a few times within a span of 1 month.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device lot #: 2115499 was reported, however, this is not a lot# manufactured for this product.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that during use with 5 bd maxzero¿ needleless connector there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: when connected with our maxzero, the pump indicated high pressure.This happens for a few times within a span of 1 month.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 16-jun-2023 investigation summary five mz1000 samples were received without packaging for investigation; the customer confirmed that the samples were from lot 21125499.An unused braun infusomat spaceline set was also received to assist the investigation.The feedback provided by the customer suggests that when they use the maxzero device as part of the infusion set-up, the pump detects high pressure in the line.A visual inspection of the returned samples did reveal three samples to be slightly recessed within the maxzero.Functional testing was performed by connecting the returned samples to a 50ml bd plastipak syringe from stock and attempting to prime with fluid; fluid flow was achieved in each instance.The samples were then sent to the manufacturing site for further investigation.They confirmed that no obvious damage or manufacturing defects were observed to the device which could have caused or contributed to the customer's experience.The samples were then subjected to a flowrate test and the they confirmed the devices all performed within specifications.A review of the production records for lot 21125499 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

• 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 ; 8448235433
• MDR Report Key: 17132067
• MDR Text Key: 317247819
• Report Number: 9616066-2023-01186
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230196
• UDI-Public: (01)10885403230196
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K132413
• 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: 08/30/2023

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
• Device Operator: Other
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: 2115499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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