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

Catalog Number	303345
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd interlink¿ blunt plastic cannula experienced foreign matter, contaminated.The following information was provided by the initial reporter: an issue was observed today when using one of the new vial aspirator needles.A rubber core appeared in the medication after the rubber cap was spiked.
Event or Problem Description
It was reported that the bd interlink¿ blunt plastic cannula experienced foreign matter, contaminated.The following information was provided by the initial reporter: an issue was observed today when using one of the new vial aspirator needles ¿ a rubber core appeared in the medication after the rubber cap was spiked.
Additional Manufacturer Narrative
H6: investigation summary it was reported a rubber core appeared in the medication after the rubber cap was spiked.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a syringe with a plastic needle inserted into a vial.The other photo shows a particle inside the vial that appears to be a similar color to the vial stopper.No other defects or imperfections were observed.It could be possible the customer is not using the product as intended.Per the product specification, "bd blunt plastic cannula provides sterile needleless access into pre-slit septum iv systems and vials designed for needleless access." this unit is not for use with regular vials.A device history record review was completed for provided material number 303345, lot 1260085.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.

• Brand Name: BD INTERLINK¿ BLUNT PLASTIC 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17121338
• Report Number: 1911916-2023-00394
• Device Sequence Number: 20592647
• Product Code: FMI
• UDI-Device Identifier: 00382903033454
• UDI-Public: 00382903033454
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 303345
• Device Lot Number: 1260085
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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