MAUDE Adverse Event Report: BECTON DICKINSON CANNULA BLUNT PLASTIC; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303345
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 303345 batch number#: 4060239 verbatim#: we had a bd blunt plastic cannula that broke while trying to draw medication, the ref number is 303345 lot 4060239.This has been the only occurrence that i am aware of, i have the needle if you want to evaluate.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported the plastic cannula that broke while trying to draw medication.To aid in the investigation, one sample in an opened packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed, and the cannula tip is bent.The photo provided shows the sample received.No other defects or imperfections were observed.A device history record review was completed for provided material number 303345, lot 4060239.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: CANNULA BLUNT PLASTIC
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20833378
• Report Number: 1911916-2024-00867
• Device Sequence Number: 18288833
• Product Code: FMI
• UDI-Device Identifier: 00382903033454
• UDI-Public: (01)00382903033454(11)240229(17)290531(10)4060239
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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): 01/05/2025

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: Health Professional
• Device Catalogue Number: 303345
• Device Lot Number: 4060239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/05/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown