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 Codes	Leak/Splash (1354); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd interlink¿ vial access cannula dislodged the stopper into the vial causing leakage.The following information was provided by the initial reporter: when accessing a medication vial with the twin-pack replacements instead of puncturing the rubber plug, it punches it into the vial and the medication pours out.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd interlink¿ vial access cannula dislodged the stopper into the vial causing leakage.The following information was provided by the initial reporter: when accessing a medication vial with the twin-pack replacements instead of puncturing the rubber plug, it punches it into the vial and the medication pours out.
Additional Manufacturer Narrative
Investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.
Event or Problem Description
It was reported that the bd interlink¿ vial access cannula dislodged the stopper into the vial causing leakage.The following information was provided by the initial reporter: when accessing a medication vial with the twin-pack replacements instead of puncturing the rubber plug, it punches it into the vial and the medication pours out.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 19-dec-2022.H6.Investigation summary: it was reported there were multiple issues when using the product.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.As the lot provided is 'unknown,' a device history record review could not be completed.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.

• 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 ; 8015296192
• MDR Report Key: 15906873
• Report Number: 1911916-2022-00692
• Device Sequence Number: 5391062
• Product Code: FMI
• UDI-Device Identifier: 30382903033677
• UDI-Public: (01)30382903033677
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 01/10/2023

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: UNKNOWN
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 01/09/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 01/03/2023; 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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