MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MON SYRING; INSTRUMENT, SURGICAL, DISPOSABLE

Catalog Number	8881135609
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd mon barrel syringe had foreign matter.The following information was received by the initial reporter with the verbatim: qc rejected 9 syringes during incoming visual inspections due to particulates discovered on the rubber stoppers.Syringe, sterile, monoject barrel, rodless, 35ml, pk10, covidien.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Customer returned 9 samples in photos, no physical samples were returned.The complaint of foreign matter was confirmed by the photos.The photos were escalated to the syringe supplier for further investigation.The supplier, cardinal health, was given ample time to complete an investigation but was only able to provide the following: the device history record for each lot affected was review, showed that manufacturing and inspection product was performed as per applicable procedures and validated process.All inspection results was carry out and were within acceptable criteria as per established sampling plan levels quality procedures.Additional no ncrs opened during manufacturing process.No formal closure letter or acknowledgement of the failure was provided.The root cause for the issue is unknown without the supplier investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: BD MON SYRING
• Common Device Name: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18117139
• Report Number: 9616066-2023-02176
• Device Sequence Number: 12509476
• Product Code: KDC
• UDI-Device Identifier: 20884521155746
• UDI-Public: (01)20884521155746
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 2215809964
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 11/11/2023
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown