MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP5314C-BNS

Device Problem Component Missing (2306)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

It was reported by customer that " 79 bd maxplus¿ extension set are missing connectors from one end." the following information was provided by the initial reporter: bd maxplus¿ extension set are missing connectors needleless connector extension set missing connectors from one end, lot 21129130.

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary: a complaint of sets missing connector was received from the customer.30 samples were returned for investigation.Through comparison with the assembly drawing, the customer complaint of misassemble was confirmed.All samples were missing the nac plus component.A device history record review for model mp5314c-bns lot number 21129130 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.To define the root cause, an audit was carried out in the production line with a similar model where accumulated material was observed due to the rest time.At the end of the rest time, the nac component is placed on all the sets, and the flow test is carried out.Therefore, the accumulation can cause confusion between the material with nac and without nac and pass incorrectly assembled sets directly to sealing.A quality alert was issued to all involved personnel to prevent this defect in the future.

Event Description

It was reported by customer that " 79 bd maxplus¿ extension set are missing connectors from one end." the following information was provided by the initial reporter: bd maxplus¿ extension set are missing connectors needleless connector extension set missing connectors from one end, lot 21129130.

• Brand Name: BD MAXPLUS¿ EXTENSION SET
• 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: 16441171
• MDR Text Key: 310246162
• Report Number: 9616066-2023-00269
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP5314C-BNS
• Device Lot Number: 21129130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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