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

Catalog Number	MX4436
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 2 bd maxguard¿ extension sets with needleless y-site, stopcock and manifold each from lots 22119025 and 2319085 had issues with breakage near the manifold.The following information was provided by the initial reporter: "mx4436 is breaking near the manifold this occurred 2x w/ 2 different lot #'s.3.Was this noted on before use or during/after use? this was noted prior to use 4.Was there any patient involvement? was there any adverse event or serious injury? no 5.What procedure was being done during the incident? tubing was pulled to prepare patient for surgery 6.Was there any leakage found? no item was defective in packaging 7.What medication/solution was used during the incident? none".
Event or Problem Description
It was reported that 2 bd maxguard¿ extension sets with needleless y-site, stopcock and manifold each from lots 22119025 and 2319085 had issues with breakage near the manifold.The following information was provided by the initial reporter: "mx4436 is breaking near the manifold this occurred 2x w/ 2 different lot #'s.3.Was this noted on before use or during/after use? this was noted prior to use.4.Was there any patient involvement? was there any adverse event or serious injury? no.5.What procedure was being done during the incident? tubing was pulled to prepare patient for surgery 6.Was there any leakage found? no item was defective in packaging.7.What medication/solution was used during the incident? none".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 07-jun-2023.H6: investigation summary two samples of material mx4436 was returned for quality investigation.The customer complaint was verified by visual inspection of the tubing.Investigation of the samples submitted show that one of the tubing samples was cracked at the extension set manifold port, and the other samples was broken at the luer connector.Further investigation of the breaks indicates that a large amount of force was applied at the connection location creating the failure.A device history record review for model mx4436 lot number 23019085 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this failure could not be determined based on the information provided and the investigation conducted at the manufacturing facility.The investigation at the manufacturing facility did not identify any part of the production process that would have applied the type of force needed to break the tubing at the locations seen in the samples.Additionally, the customer stated they received the product already broken in the package.The possible root cause for the failure is that the infusion set was damaged during transportation.

• Brand Name: BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD
• 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 ; 8448235433
• MDR Report Key: 17052217
• Report Number: 9616066-2023-01069
• Device Sequence Number: 14316479
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: 10885403237478
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/15/2023

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
• Operator of Device: Other
• Device Expiration Date: 11/05/2025
• Device Catalogue Number: MX4436
• Device Lot Number: 22119025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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