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

Catalog Number MZ9266

Device Problem Component Missing (2306)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector was missing a piece.The following information was provided by the initial reporter: 1 product missing a piece, came in package that way.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: one sample of extension set mz9266 was submitted for quality investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample submitted shows that one of the tri-fuse tubes is short and cut, without a maxzero connector attached to the assembly.A device history record review for model mz9266 lot number 22119144 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Based on the information provided by the customer and the investigation of the product sample submitted, the root cause of the misassembly can be attributed to the manufacturing process.The tubing appears cut shorter than specification and missing a connector.Additionally, the customer stated that the extension set was received with the issue inside the packaging.The investigation for the failure was forwarded to the manufacturing location for further investigation.The investigation at the manufacturing location concluded that the root cause for the failure was an incorrect placement of the set inside an assembly cavity, along with a later error in the inspection of the parts.

Event Description

It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector was missing a piece.The following information was provided by the initial reporter: 1 product missing a piece, came in package that way.

• Brand Name: BD MAXZERO¿ MULTI-FUSE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16892600
• MDR Text Key: 314866528
• Report Number: 9616066-2023-00851
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240782
• UDI-Public: 10885403240782
• 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: 08/23/2023

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 Catalogue Number: MZ9266
• Device Lot Number: 22119144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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