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

Catalog Number MZ9267

Device Problems Leak/Splash (1354); Incomplete or Inadequate Connection (4037)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

It was reported that 2 bd maxzero multi-fuse extension set with needleless connector(s) experienced the luer connection being unable to connect to the mating component.The following information was provided by the initial reporter: its leaking at the max zero on the medication tubing.No matter how many times we screw on the syringe, the max connector leaks as it will not properly connect with the syringe.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following information has been updated/corrected: b.5.Describe event or problem: it was reported that 9 bd maxzero multi-fuse extension sets with needleless connector(s) experienced the luer connection being unable to connect to the mating component.The following information was provided by the initial reporter: its leaking at the max zero on the medication tubing.No matter how many times we screw on the syringe, the max connector leaks as it will not properly connect with the syringe.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 21095420.D.4.Medical device expiration date: 2024-09-20.H.4.Device manufacture date: 2021-09-06.D.4.Medical device lot #: 21105940.D.4.Medical device expiration date: 2024-10-21.H.4.Device manufacture date: 2021-10-14.D.4.Medical device lot #: 21095419.D.4.Medical device expiration date: 2024-09-20.H.4.Device manufacture date: 2021-09-06.D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.

Event Description

It was reported that 9 bd maxzero multi-fuse extension sets with needleless connector(s) experienced the luer connection being unable to connect to the mating component.The following information was provided by the initial reporter: its leaking at the max zero on the medication tubing.No matter how many times we screw on the syringe, the max connector leaks as it will not properly connect with the syringe.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 07-mar-2022.H6: investigation summary: four samples of item# mz9267, lot# 21105940 were submitted for quality investigation.The samples were tested as received, with a 3ml bd syringe attached.The 3ml bd syringe that was attached to three of mz9267 extension sets and one coviden syringe was connected to the mz9267 extensions set.The syringes were filled with water and reconnected to the maxzero connectors of the extension sets.When pushing the water through the extension set leakage was noticed at the joint location between the syringe and maxzero.A new 3ml bd syringe (lot# 0183088) was provided by the customer and was tested with the extension sets submitted.The new syringe with the maxzero extension set did not show any signs of leakage.The customer complaint of connection issues and leakage due to the maxzero connector could not be verified.A device history record review for model mz9267 lot number 21105940 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21oct2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Based on the investigation, the root cause for the issue seen in this complaint was not caused by the maxzero connector but by the syringe that it was connected to.Three samples of item# mz9267, lot# 21095420 were submitted for quality investigation.The samples were tested as received, with a 3ml bd syringe attached.The 3ml bd syringe that was attached to the mz9267 extension sets were filled with water and reconnected to the maxzero connectors of the extension sets.When pushing the water through the extension set leakage was noticed at the joint location between the syringe and maxzero.A new 3ml bd syringe (lot# 0183088) was provided by the customer and was tested with the extension sets submitted.The new syringe with the maxzero extension set did not show any signs of leakage.The customer complaint of connection issues and leakage due to the maxzero connector could not be verified.A device history record review for model mz9267 lot number 21095420 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Based on the investigation, the root cause for the issue seen in this complaint was not caused by the maxzero connector but by the syringe that it was connected to.Two new samples of item# mz9267, lot#21095419 was submitted for quality investigation.The samples were tested with a new item# mz9267 3ml syringe, lot# 1118091.Water was drawn into the syringe and connected to the extension set.The liquid was then pushed through the entire assembly.There was no leakage observed during testing.The extension set was then connected to a 3 ml syringe that had previously shown leakage with the same model extension set.When testing the extension set with that specific syringe, leakage was observed at the connection point with the maxzero.The customer complaint of connection issue and leakage could not be verified.A device history record review for model mz9267 lot number 21095419 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Based on the investigation, the root cause for the issue seen in this complaint was not caused by the maxzero connector but by the syringe that it was connected to.Two samples of item# mz9267, with unknown lot number were submitted for quality investigation.The samples were tested with a new item# mz9267 3ml syringe, lot# 0183088.Water was drawn into the syringe and connected to the extension set.The liquid was then pushed through the entire assembly.There was no leakage observed during testing.The extension set was then connected to a 3 ml syringe that had previously shown leakage with the same model extension set.When testing the extension set with that specific syringe, leakage was observed at the connection point with the maxzero.The customer complaint of connection issues and leakage due to the maxzero connector was not verified.A device history record review could not be performed because the lot number is unknown.Based on the investigation, the root cause for the issue seen in this complaint was not caused by the maxzero connector but by the syringe that it was connected to.

Event Description

It was reported that 9 bd maxzero multi-fuse extension sets with needleless connector(s) experienced the luer connection being unable to connect to the mating component.The following information was provided by the initial reporter: its leaking at the max zero on the medication tubing.No matter how many times we screw on the syringe, the max connector leaks as it will not properly connect with the syringe.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• 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: 13524066
• MDR Text Key: 286563694
• Report Number: 9616066-2022-00119
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• 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,Followup
• Report Date: 03/22/2022

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 Catalogue Number: MZ9267
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 02/18/2022; 03/22/2022
• Supplement Dates FDA Received: 03/19/2022; 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2021
• 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