MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL W/BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303347
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 5ml ll w/blunt plastic cannula broke off in vial.The following information was provided by the initial reporter: this is a picture of the product that we have seen the tip brake off of several times in vials of medication.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary two photos were provided to our quality team for investigation.Please note that bd syringes with blunt plastic cannula are specifically designed for use with preslit injection sites.They are not compatible with other injection sites.Since the photos received did not indicate proper usage of the product a potential root cause could not be defined and corrective actions are not necessary.Furthermore, a device history record review was completed for provided lot number 2054022.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
It was reported that the bd syringe 5ml ll w/blunt plastic cannula broke off in vial.The following information was provided by the initial reporter: this is a picture of the product that we have seen the tip brake off of several times in vials of medication.

• Brand Name: BD SYRINGE 5ML LL W/BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15463923
• Report Number: 1213809-2022-00614
• Device Sequence Number: 17860932
• Product Code: FMI
• UDI-Device Identifier: 30382903033479
• UDI-Public: (01)30382903033479
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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 Model Number: 303347
• Device Catalogue Number: 303347
• Device Lot Number: 2054022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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