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 Leak/Splash (1354)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

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 that the bd maxzero¿ needleless connector leaked from the iv tubing.The following information was provided by the initial reporter: "noted chemo iv line that has ifos/mesna was leaking at bd needleless connector and iv tubing.It had not gotten on patient's clothing or anywhere else.Changed iv tubing, caps and y connector.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-11.H6: investigation summary 6 samples and a set from a different company were returned for investigation.Through visual inspection, no defects or damages were seen on the connectors.Samples were flushed and no leakage was observed.Each sample was connected to a primary set (2420-0007) and infused at a rate of 530 ml/hr to recreate the customers situation.No leakages or issues were observed during infusion.An infusion could not be performed with the set returned because it was not compatible with the pumps in the lab.The samples were then primed with the returned non-bd set and leakage was at the connection site of the maxzero and the sets luer.A device history record review for model mz1000-07 lot number 21075185 was performed.The search showed that a total of 76,803 units in 1 lot number was built on 15jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that the bd maxzero¿ needleless connector leaked from the iv tubing.The following information was provided by the initial reporter: "noted chemo iv line that has ifos/mesna was leaking at bd needleless connector and iv tubing.It had not gotten on patient's clothing or anywhere else.Changed iv tubing, caps and y connector.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12712426
• MDR Text Key: 278808823
• Report Number: 9616066-2021-52321
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230194
• UDI-Public: 50885403230194
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: 21075185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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