MAUDE Adverse Event Report: CAREFUSION SD MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number MZ1000-07

Device Problems Difficult to Remove (1528); Difficult or Delayed Separation (4044)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that maxzero needleless connector was stuck in the tubing.The following information was provided by the initial reporter: material no: mz1000-07, batch no: unknown.It was reported that maxzero was stuck in filter tubing.Customer response 03-sep-2020: the products are stuck together.Unsure if the problem is due to the maxzero mz 1000-07 or the 1.2 micron filter 20129e.Both products are involved.Unfortunately, i do not have any other identifying information for these products as they were discarded.Customer response 01-sep-2020: hello¿below is the information that i have available.Can you describe the reported defect in detail? what happened? what was the cause? who was involved? maxzero stuck in filter tubing.Unsure of the cause.Nurse was preparing to give medications.Can you provide the date(s) for the reported failure(s)? (b)(6) 2020.Was there any adverse event(s) as a result of the reported defect? no.If yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.) and date.Are you able to provide the batch/lot no.For the extension tubing reported? no, no packaging was saved.

Manufacturer Narrative

It was reported that the maxzero was unable to disconnect from the filter set.Received one used maxzero needless connector model mz1000-07 lot unknown attached to the male luer of one used extension filter set model 20129e lot unknown.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Residual fluid was observed that the connection between the set¿s male luer and female inlet port of the maxzero.No anomalies or damages were observed with the set.Functional testing was performed by attaching a 10ml lab syringe filled with blue dye water to the extension set¿s female luer.The syringe plunger was gently depressed and no disconnections, leaks or any issues were observed.The set was then loaded into a lab syringe module.An infusion rate was not provided, therefore the syringe infusion was programmed at a rate of 10ml/h and vtbi of 10ml.The infusion completed with no alarms, disconnections, or any issues.Model mz1000-07 was detached from the extension set without any difficulties.The maxzero was reattached to the extension set and was pressure tested while submerged underwater (per dir #10000360033 ¿ iv disposable leak test method).Air pressure was incrementally increased from 5 psi to 30 psi.No disconnections or leaks were observed at any of the set¿s components, connections, or throughout the set.The set and maxzero¿s female/male luer ports were measured and found to be within iso standards with the female/male go/nogo gauges.Equipment used (measurement and testing performed on 24sep2020).Air pressure regulator with pressure gauge, eq00151, calibration due date: 07nov2020.8015 alaris pcu 1.5, eq10291, calibration due date: 20mar2021.8100 alaris system syringe, eq08313, calibration due date: 04aug2021.Male go/no go gauge, eq08244, calibration due date: 14sep2021.Female go/no go gauge, eq08248, calibration due date: 14sep2021.A device history record could not be performed due to no lot number was provided by the customer.The customer¿s report that the maxzero was unable to disconnect from the filter set was not confirmed.The root cause of the customer¿s experience was not identified because the maxzero detached from the set without any difficulties and no issues were replicated during functional testing.

Event Description

It was reported that maxzero needleless connector was stuck in the tubing.The following information was provided by the initial reporter: material no: mz1000-07 batch no: unknown.It was reported that maxzero was stuck in filter tubing.Customer response 03-sep-2020: the products are stuck together.Unsure if the problem is due to the maxzero mz 1000-07 or the 1.2 micron filter 20129e.Both products are involved.Unfortunately, i do not have any other identifying information for these products as they were discarded.Customer response 01-sep-2020: hello¿below is the information that i have available.Can you describe the reported defect in detail? what happened? what was the cause? who was involved? maxzero stuck in filter tubing.Unsure of the cause.Nurse was preparing to give medications.Can you provide the date(s) for the reported failure(s)? 3/20/2020.Was there any adverse event(s) as a result of the reported defect? no.If yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.) and date.Are you able to provide the batch/lot no.For the extension tubing reported? no, no packaging was saved.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10570898
• MDR Text Key: 234623187
• Report Number: 9616066-2020-02787
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230196
• UDI-Public: 10885403230196
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

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: Health Professional
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20129E,; 20129E,
• Patient Outcome(s): Other