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

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 during use with bd maxguard¿ extension set the blue end cap was missing.There was no patient impact.The following information was provided by the initial reporter: it was reported by customer that 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.

Event Description

It was reported that during use with bd maxguard¿ extension set the blue end cap was missing.There was no patient impact.The following information was provided by the initial reporter: it was reported by customer that 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

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 05-jul-2023 h6: investigation summary a complaint of set missing a blue cap was received from the customer.A sample was received for investigation.Through visual inspection, no defects or damages were noted on the set.Cap was seen to be assembled on set.The set was then primed with a syringe, and no connection issues or leakage were observed.The male luer was then attached to a primary set and no issues were noted during connection of the male luer.The defect could not be replicated.A device history record review for model me1055 lot number 22129078 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 defect not being able to be replicated, a root cause could not be determined.H3 other text : see h10.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17224304
• MDR Text Key: 318097922
• Report Number: 9616066-2023-01314
• 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: 07/11/2023

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 Model Number: ME1055
• Device Catalogue Number: ME1055
• Device Lot Number: 22129078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2022
• 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