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

Catalog Number MZ5309

Device Problem Material Fragmentation (1261)

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

Event Date 07/09/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 23039213.D.4.Medical device expiration date: 12-mar-2026.H.4.Device manufacture date: 12-mar-2023.D.4.Medical device lot #: 23029117.D.4.Medical device expiration date: 04-feb-2026.H.4.Device manufacture date: 03-feb-2023.H.3.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 at least one bd maxzero¿ multi-fuse pressure rated extension set with needleless connector each from lots 23039213 and 23029117 had issues with their connections chipping during use.The following information was provided by the initial reporter: "it is not a filter but a blue connection.When not in use for inpatients they are covered by a curos cap (also plastic).Our concern is these blue components are easily chipped (from various lot numbers) and it is unclear what happens to this material-such as a concern for embolus/foreign body injected when it is accessed.I have seen chips in the material in extension tubing that has been in place a few days or when just pre priming the extension tubing with saline prior to starting an iv.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-aug-2023.H6: investigation summary a complaint of damage on a blue connector was received from the customer.A sample of lot 23029117 and two samples of an unknown lot were received for investigation.Through visual inspection, the customer complaint was confirmed.The maxzeros were chipped on the blue component.A device history record review for model mz5309 lot number 23029117 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect and an investigation was performed.After the investigation and along with manufacturing and quality operations team, it was not able to identify that this condition was generated in the manufacturing process.Evidence led to define that a sharp luer or needle or an external condition generated the damage in the valve that eventually generated the damage.

Event Description

It was reported that at least one bd maxzero¿ multi-fuse pressure rated extension set with needleless connector each from lots 23039213 and 23029117 had issues with their connections chipping during use.The following information was provided by the initial reporter: "it is not a filter but a blue connection.When not in use for inpatients they are covered by a curos cap (also plastic).Our concern is these blue components are easily chipped (from various lot numbers) and it is unclear what happens to this material-such as a concern for embolus/foreign body injected when it is accessed.I have seen chips in the material in extension tubing that has been in place a few days or when just pre priming the extension tubing with saline prior to starting an iv.".

• Brand Name: BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17421506
• MDR Text Key: 320132814
• Report Number: 9616066-2023-01574
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403242083
• UDI-Public: 10885403242083
• 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
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ5309
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• 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