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

Catalog Number	303345
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
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
Material #:303345 and batch#: 4178837.It was reported by customer that 2 bx 303345 are breaking when trying to administer a vaccine.Verbatim: rcc received a complaint via email.Lot box 4178837.2 bx 303345 are breaking when trying to administer a vaccine.
Additional Manufacturer Narrative
Follow up mdr for additional information received by the customer.Following the submission of the initial mdr, additional information was received (see b5).Annex a code updated to reflect additional information.
Event or Problem Description
Additional information received by customer: in further speaking with the charge nurse, she said that when she was drawing up the vaccine with the plastic cannula it was not easy to use.Had to put more pressure to push into the vaccine rubber stopper.Pieces of the vaccine stopper were cut and went into vaccine.Vaccine vial was unusable.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported pieces of the vaccine stopper were cut and went into vaccine.To aid in the investigation, one hundred ninety-one samples in sealed packaging blisters were received for evaluation by our quality team.Eighty samples were randomly selected for investigation.A visual inspection was performed, and no cracks or damaged were observed to the cannula tip.There were no defects or imperfections.A device history record review was completed for provided material number 303345, lot 4178837.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 could not be 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: 20770823
• Report Number: 1911916-2024-00842
• Device Sequence Number: 4301041
• Product Code: FMI
• UDI-Device Identifier: 00382903033454
• UDI-Public: (01)00382903033454(11)240626(17)290930(10)4178837
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 12/14/2024

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: Health Professional
• Device Catalogue Number: 303345
• Device Lot Number: 4178837
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 12/12/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 11/26/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown