MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTERLINK¿ VIAL ACCESS CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303367
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the bd interlink¿ vial access cannula broke off and cut the nurse's skin.The following information was provided by the initial reporter: "when the nurse was using the cannula, the plastic of the device snapped, resulting in the sharp tip of the plastic cutting the nurse's skin".
Additional Manufacturer Narrative
H.3.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 the tip of the bd interlink¿ vial access cannula broke off and cut the nurse's skin.The following information was provided by the initial reporter: "when the nurse was using the cannula, the plastic of the device snapped, resulting in the sharp tip of the plastic cutting the nurse's skin".
Additional Manufacturer Narrative
H6: investigation summary it was reported the plastic of the device snapped.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show four sealed packaging blisters from the top web and from the bottom web.No other information could be obtained from the photos.A device history record review was completed for provided material number 303367, lot 1300479.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 photo sample analysis the symptom reported by the customer could not be confirmed.H3 other text : see h10.

• Brand Name: BD INTERLINK¿ VIAL ACCESS CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17927352
• Report Number: 1911916-2023-00767
• Device Sequence Number: 15154537
• Product Code: FMI
• UDI-Device Identifier: 00382903033676
• UDI-Public: 00382903033676
• 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
• 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): 10/12/2023

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: 1300479
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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