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	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2104000964; medical device expiration date: 31-jan-2026; device manufacture date: 25-mar-2021.Medical device lot #: 2113123264; medical device expiration date: 30-apr-2026; device manufacture date: jun-07-2021.Medical device lot #: 2100529264; medical device expiration date: 31-dec-2025; device manufacture date: 5-aug-2021.Medical device lot #: 2025508564; medical device expiration date: 31-aug-2025; device manufacture date: 27-oct-2020.Medical device lot #: 2121700164; medical device expiration date: 31-jul-2026; device manufacture date: 17-sep-2021.Medical device lot #: 2115319764; medical device expiration date: 31-may-2026; device manufacture date: 07-jun-2021.Medical device lot #: 2024517264; medical device expiration date: 31-aug-2025; device manufacture date: 21-aug-2020.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 7 bd 35ml monoject¿ syringe barrels experienced foreign matter contamination.The following information was provided by the initial reporter: particulates and fibers detected on the syringe plunger during qc incoming inspection.
Event or Problem Description
It was reported that 7 bd 35ml monoject¿ syringe barrels experienced foreign matter contamination.The following information was provided by the initial reporter: particulates and fibers detected on the syringe plunger during qc incoming inspection.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of fibers and particles being found on syringes was received from the customer.20 samples of lot 2025508564 were returned for investigation.Through visual inspection, the customer complaint was confirmed.Two syringes had black smudges on them.One had a hair on the plunger.And two other syringes had a clear sticky substance on them.The supplier of the syringes was notified of the defect.The device history records (dhr) were reviewed by the supplier, and no abnormal process conditions were present during the manufacturing of the products that could have led to the reported conditions.The dhr reviews showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.An investigation was performed by the supplier and the clear substance was determined to be silicon that is put into the grommet used during manufacturing.The root cause for this defect is improperly performing qc visual inspections.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: 14120558
• Report Number: 9616066-2022-00381
• Device Sequence Number: 11351904
• 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): 08/05/2022

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: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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