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

Catalog Number	8881135609
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
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 was broken.The following information was received by the initial reporter with the verbatim: they discovered a monoject syringe where the tip has broken off.It is the taller section inside the tip barrel.Customer said she does still have the sample of affected syringe.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported by the customer that they discovered a monoject syringe where the tip has broken off, and returned a photo of material 8881135609, lot 2217912864.The photo verified the complaint, the luer post on the syringe was broken off.The photo and investigation were escalated to the syringe supplier, cardinal health.The cardinal health investigation was only able to provide the dhr: 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.Quantity manufactured: (b)(4) units date manufactured: 6/29/2022 the root cause is unknown without the supplier sample 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.

• 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: 18080777
• Report Number: 2243072-2023-02005
• Device Sequence Number: 17799470
• 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): 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: 2217912864
• 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: 05/01/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown