MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD MON SYRINGE BARREL ASSEMBLY; INSTRUMENT, SURGICAL, DISPOSABLE

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	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 bd mon syringe barrel assembly had foreign matter.The following information was received by the initial reporter with the verbatim: they discovered a monoject syringe with a brown particle stuck in the syringe wall.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr (b)(4) - follow up mdr for device evaluation.The customer reported a brown particle in the wall of the syringe, and returned the sample.The sample was visually inspected, and the complaint of foreign matter was verified.There is a foreign body within the syringe wall near the 10 ml mark.The photo of the issue was forwarded to the syringe supplier, and they confirmed the failure.The supplier conducted the device history record review with material#: 8881135609 and batch#: 2213015864 which showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There was no official root cause able to be found for the issue, but a potential root cause is that the manufacturing or quality processes were not followed correctly.An awareness notification was sent to production personnel regarding this foreign matter issue.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.

• Brand Name: BD MON SYRINGE BARREL ASSEMBLY
• Common Device Name: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• 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: 18070219
• Report Number: 9616066-2023-02142
• Device Sequence Number: 12666482
• Product Code: KDC
• UDI-Device Identifier: 20884521155746
• UDI-Public: (01)20884521155746
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/08/2024

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: 2213015864
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/04/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown