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

Model Number ME1055

Device Problem Component Missing (2306)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 maxguard¿ extension set experienced a missing component.The following information was provided by the initial reporter: the top extension set does not have this light blue tip, and they are unable to push the threaded part down.They are then unable to connect to the bronchoscope.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of misassembly (missing component) could not be verified due to the product not being returned for failure investigation.A device history record review for model me1055 lot number 23039002 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.H3 other text : see h10.

Event Description

It was reported that the bd maxguard¿ extension set experienced a missing component.The following information was provided by the initial reporter: the top extension set does not have this light blue tip, and they are unable to push the threaded part down.They are then unable to connect to the bronchoscope.

• Brand Name: BD MAXGUARD¿ 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17302410
• MDR Text Key: 319698954
• Report Number: 9616066-2023-01407
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236020
• UDI-Public: (01)10885403236020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ME1055
• Device Catalogue Number: ME1055
• Device Lot Number: 23039002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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