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

Model Number	41134E
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 gravity administration set experienced foreign matter.The following information was provided by the initial reporter: one of our pre-op nurses noticed a lubricant around the spike on lawson.
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint of customer finding lubricant around spike was received.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.There was a light yellow substance found on the spike.A device history record review for model 41134e lot number 22039220 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of the defect.The root cause was determined to be an issue at the supplier of this component.The supplier was notified of this defect.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd gravity administration set experienced foreign matter.The following information was provided by the initial reporter: one of our pre-op nurses noticed a lubricant around the spike on lawson.

• 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: 15131537
• Report Number: 9616066-2022-01000
• Device Sequence Number: 14827614
• Product Code: FPA
• UDI-Device Identifier: 50885403235281
• UDI-Public: 50885403235281
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 08/01/2022

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: 03/15/2025
• Device Model Number: 41134E
• Device Catalogue Number: 41134E
• Device Lot Number: 22039220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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