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	Foreign Body In Patient (2687)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the patient was under anesthesia, the tip of the bd interlink¿ vial access cannula broke off into them and the operator "dug it out" during the procedure.The following information was provided by the initial reporter: "we were notified of a complaint from a customer stating component broke off into patient and had to be dug out during procedure.Defect description: component broke off into patient and had to be dug out during procedure.What was the procedure being performed? ecmo procedure.Were all pieces able to be recovered from the patient? yes.Was there any need for medical treatment or intervention? patient was under prolonged anesthesia.No injury or medical intervention.Where did the device break off in the patient? the piece attached to the syringe fell off and into the patient.How was the device removed from the patient? end user had to dig it out of the patient.Were there any diagnostics that were performed to confirm there were no retained objects left in the patient? unknown".
Additional Manufacturer Narrative
Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda via medwatch # 1423395-2023-00009.Device manufacture date: unknown.Investigation summary: it was reported the component broke off into patient and had to be dug out during procedure.As a sample was not returned, a thorough sample investigation could not be completed.It could be possible the customer was not using this product as intended.This product is specified to be used for penetrating a single dose drug vial.As the lot provided is unknown, a device history record review could not be completed.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.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.

• 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: 16629276
• Report Number: 1911916-2023-00182
• Device Sequence Number: 17460092
• Product Code: FMI
• UDI-Device Identifier: 00382903033676
• UDI-Public: 00382903033676
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/27/2023

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: UNKNOWN
• 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: 03/08/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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