MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 35ML MONOJECT¿ SYRINGE BARREL; PISTON SYRINGE

Catalog Number	8881135609
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that foreign matter was discovered on bd 35ml monoject¿ syringe barrel.The following information was provided by the initial reporter: it was reported syringes with particulates on the plunger / fm.
Event or Problem Description
It was reported that foreign matter was discovered on bd 35ml monoject¿ syringe barrel.The following information was provided by the initial reporter: it was reported syringes with particulates on the plunger / fm.
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint of foreign matter being found on syringes was received from the customer.22 opened samples of different lots were received for investigation.Through visual inspection, the defect could not be confirmed.The samples all had black writing on them that smudged making it difficult to find the small black particles.The supplier of this product was notified and an investigation was performed.The device history record (dhr) for the reports lots were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr reviews showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A potential root cause for particulate on the barrel component can be a result of contamination during the transfer of the barrel component.Plastic debris can buildup on the work holders at the printer which may introduce particulate to the barrel as it is being transferred or from buildup on the bulk conveyor hopper which transfers parts into the final shipper case.Other potential causes for particulate contamination can be a result of further handling and/or processing.Current process controls are executed in accordance with product specifications and include the cleaning of the bulk conveyor/ hopper to meet quality acceptance criteria.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 h10.

• Brand Name: BD 35ML MONOJECT¿ SYRINGE BARREL
• Common Device Name: PISTON SYRINGE
• 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: 13178256
• Report Number: 9616066-2021-52686
• Device Sequence Number: 19988642
• Product Code: FMF
• UDI-Device Identifier: 20884521155746
• UDI-Public: 20884521155746
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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 Catalogue Number: 8881135609
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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