MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD 20MM SMARTSITE VAD-ZYMOGENETICS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10016240
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported by customer that the bd 20mm smartsite vad-zymogenetics had some type of debris in packaging.The following information was provided by the initial reporter: "some type of debris in packaging".
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 a complaint of debris in packaging was received from the customer.A sample was received where the defect was confirmed.A device history record review for model 10016240 lot number 22115303 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Previous investigations found that insufficient maintenance for the mold used in production and not following the instructions of keeping material covered until use to be the contributors of the foreign matter found in the packaging.This lot was manufactured prior to the corrective actions for this defect were implemented.
Event or Problem Description
It was reported by customer that the bd 20mm smartsite vad-zymogenetics had some type of debris in packaging.The following information was provided by the initial reporter: "some type of debris in packaging".

• Brand Name: BD 20MM SMARTSITE VAD-ZYMOGENETICS
• 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: 17107571
• Report Number: 9616066-2023-01152
• Device Sequence Number: 20351297
• Product Code: FPA
• UDI-Device Identifier: 50885403270916
• UDI-Public: (01)50885403270916
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K223088
• 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): 06/12/2023

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 Catalogue Number: 10016240
• Device Lot Number: 22115303
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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