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

Catalog Number	42519E
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a complaint of the connection being loose, causing leakage was received from the customer.Two samples were returned for investigation.Through visual inspection, no defects or damages were observed on the sets.The two sets were then primed, and no leakage was observed on the set.The two sets were attached to a primary set (2425-0500) and an infusion was run at 250 ml/hr.No leakage was observed.No other defects were seen.A device history record review for model 42519e lot number 22059085 was performed.The search showed that a total of (b)(4) units in 2 lot numbers were built on 09may2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to the defect not being able to be replicated, a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 2 of the bd gravity administration sets were loose and leaking.The following information was provided by the initial reporter: hi, i have 2 defective iv sets reference# (b)(4).They are both the same lot number (10)22059085.They had loose and leaking connections.

• Brand Name: BD GRAVITY ADMINISTRATION SET
• 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: 16005239
• Report Number: 9616066-2022-01984
• Device Sequence Number: 5767261
• Product Code: FPA
• UDI-Device Identifier: 07613203010870
• UDI-Public: 07613203010870
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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
• Report Date (Section B): 12/01/2022

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: Other
• Device Expiration Date: 05/09/2025
• Device Catalogue Number: 42519E
• Device Lot Number: 22059085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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