MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD INTERLINK¿ BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303345
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the when the bd interlink¿ blunt plastic cannula is pushed into a vial, it will break off a piece of the rubber from inside the vial (coring).This occurred multiple times, however, no patient impact reported.The following information was provided by the initial reporter: one of our rns brought up a concern about the bd blunt plastic cannula.He said this is the 2nd time he has noticed that the blunt cannula, when pushed into a vial, will break off a piece of the rubber from inside the vial.
Additional Manufacturer Narrative
Date of event is unknown.Investigation summary: it was reported when the product is pushed into a vial, it will break off a piece of the rubber off into the vial.To aid in the investigation, one hundred samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens and no defects or imperfections were observed.It could be possible the customer is not using the product as intended.If the product is not meeting the customer¿s needs, it may be beneficial to contact the local bd sales, or marketing representative, for additional product options.A device history record review was completed for provided material number 303345, lot number 2027209.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INTERLINK¿ BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14435056
• Report Number: 1911916-2022-00263
• Device Sequence Number: 12019203
• Product Code: FMI
• UDI-Device Identifier: 00382903033454
• UDI-Public: 00382903033454
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: 303345
• Device Lot Number: 2027209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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