MAUDE Adverse Event Report: BECTON DICKINSON CANNULA INTERLINK VIAL ACCESS; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303367
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
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 #303367 batch # 4305196 it was reported by customer that the cannulas breaking/snapping when prepping meds.Verbatim: cannulas breaking/snapping when prepping meds.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.An issue was reported involving cannulas breaking during medication preparation.To support the investigation, five samples and one photograph were submitted for evaluation by the quality team.Of the five samples, four were received without packaging blisters, while one was enclosed in a sealed blister pack.A visual inspection was conducted on all samples.Two exhibited complete separation of the plastic needle at the junction with the needle hub, while two others showed visible cracks in the same area.The sample in the sealed blister pack was examined under 30x magnification, and no defects or abnormalities were observed.The accompanying photograph depicted four of the submitted samples.A device history record (dhr) review was completed for material number 303367, lot 4305196.The review found no quality issues or related notifications during the production of this lot.All manufacturing processes and final inspections were performed in accordance with specification requirements.Process assessments did not identify any specific stage that could have contributed to the observed damage.Additionally, interviews with associates revealed no prior observations of this condition.Based on the investigation and analysis of the returned samples, the customer-reported issue has been confirmed.

• Brand Name: CANNULA INTERLINK VIAL ACCESS
• 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: 22053396
• Report Number: 1911916-2025-00359
• Device Sequence Number: 5228820
• Product Code: FMI
• UDI-Device Identifier: 00382903033676
• UDI-Public: (01)00382903033676(11)241031(17)291231(10)4305196
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 303367
• Device Lot Number: 4305196
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown