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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6 investigation summary: it was reported the cannula is breaking when piercing the vial.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a vial with a piece of the sharp spike of the cannula interlink in a vial.Outside the vial there is the other piece of the sharp spike.No other defects or imperfections were observed.It could be possible the customer is not using the product as intended.Per product specification, "the product is to be used on preslitted interlink 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that unspecified amount the bd interlink¿ vial access cannula are breaking when attempting to insert into the vial.The following information was provided by the initial reporter: 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: 16710304
• Report Number: 1911916-2023-00224
• Device Sequence Number: 15294329
• Product Code: FMI
• UDI-Device Identifier: 00382903033676
• UDI-Public: 00382903033676
• 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
• Report Date (Section B): 04/04/2023

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 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: 03/24/2023
• Initial Report FDA Received Date: 04/10/2023
• 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 Sex: Unknown