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

Model Number	303367
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd interlink¿ vial access cannula the needle broke.There was no report of patient impact.The following information was provided by the initial reporter: the emergency department supply carts that are in each room had started being stocked with bd vial access cannulas (ref 303367, lot 2056709) for drawing up medications from vials.We have had multiple incidents of these breaking when attempting to insert into the vial due to the cannula being plastic and too blunt to effectively pierce the vial.This has resulted in employees almost stabbing their own hands after it breaks, as well as a in delay in care during acute situations due to the faulty device.
Additional Manufacturer Narrative
A.2.Patient¿s birthday was not provided, (b)(6) was used based on age of patient.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported the cannula is breaking when attempting to insert into a vial due to the cannula being too blunt.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a vial with the cannula spike in it.Next to the vial there is a needle assembly with the plastic shield, and next to the needle assembly is a plastic cannula stem with the spike.No other information could be obtained from the photo.It could be possible the customer is not using the product as intended.This unit is to be used on pre-slit interlink injection sites and is not compatible with conventional injection sites.A device history record review was completed for provided material number 303367, lot 2056709.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.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.
Event or Problem Description
It was reported while using bd interlink¿ vial access cannula the needle broke.There was no report of patient impact.The following information was provided by the initial reporter: the emergency department supply carts that are in each room had started being stocked with bd vial access cannulas (ref 303367, lot 2056709) for drawing up medications from vials.We have had multiple incidents of these breaking when attempting to insert into the vial due to the cannula being plastic and too blunt to effectively pierce the vial.This has resulted in employees almost stabbing their own hands after it breaks, as well as a in delay in care during acute situations due to the faulty device.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16778568
• Report Number: 1911916-2023-00246
• Device Sequence Number: 6849498
• Product Code: FMI
• UDI-Device Identifier: 30382903033677
• UDI-Public: (01)30382903033677
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/28/2023

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: Other
• Device Model Number: 303367
• Device Catalogue Number: 303367
• Device Lot Number: 2056709
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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 Age: 49 YR
• Patient Sex: Female