MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4450
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd maxguard¿ extension set with needleless y-site and stopcock disconnected in the middle of the tubing while the patient was receiving saline via iv.The following information was provided by the initial reporter: iv tubing was connected in periop before the patient arrived in medical/surgical/ orthopedic (mso) post operatively.Post operatively in mso the patient was receiving normal saline iv and sitting in a chair at the bedside.The nurse came in and noticed the iv was disconnected in the middle of the tubing, not near any luer connection.The iv tubing was changed, no harm to the patient.The charge nurse called quality/risk and secured the defective tubing.".
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of tubing disconnecting from the center of the tubing could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.Device history record review for model mx4450 lot number 22049030 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that the bd maxguard¿ extension set with needleless y-site and stopcock disconnected in the middle of the tubing while the patient was receiving saline via iv.The following information was provided by the initial reporter: iv tubing was connected in periop before the patient arrived in medical/surgical/ orthopedic (mso) post operatively.Post operatively in mso the patient was receiving normal saline iv and sitting in a chair at the bedside.The nurse came in and noticed the iv was disconnected in the middle of the tubing, not near any luer connection.The iv tubing was changed, no harm to the patient.The charge nurse called quality/risk and secured the defective tubing.".

• Brand Name: BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK
• Common Device Name: 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 ; 8015296192
• MDR Report Key: 15641420
• Report Number: 9616066-2022-01578
• Device Sequence Number: 6463324
• Product Code: FPA
• UDI-Device Identifier: 10885403274671
• UDI-Public: (01)10885403274671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: MX4450
• Device Lot Number: 22049030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown