MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35C

Catalog Number	515004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 before use of the bd phaseal¿ injector luer lock n35c, when taking out of the package there was white particles on blue part of the injector.There was no report of exposure, injury, or medical intervention.
Event or Problem Description
It was reported that before use of the bd phaseal¿ injector luer lock n35c, when taking out of the package there was white particles on blue part of the injector.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
H.6 investigation summary: one sample unit was received for evaluation by our quality engineer.Upon inspection of the sample, white particles were observed on the surface of the injector.Through microscopic examination, the foreign particles were identified as talc.During the assembly process, talc is used to help the membrane move through the different stations within the manufacturing machinery.The talc used is compliant with european, japanese and united states pharmacopeias.An excess of talc may have caused the observed/reported defect.To improve the cleaning procedure of the manufacturing lines, a project was implemented.Upon the implementation of the project improvements, foreign matter presence was reduced.Manufacturing personnel have been notified of this incident.Dhr was completed and no qn¿s related to the fm contamination.Investigation conclusion: 1 open and unused samples were received.There were some white particles on the injector surface.Fm was identified as talc.Root cause description: fm found seems to bel talc under microscope observation.During assembly process the talc is used to help the membrane go through the different stations of the machine.A punctual excess of talc may have caused the claimed defect.Talc used is compliant with european, japanese and united states pharmacopeias.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35C
• Common Device Name: INJECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7846775
• Report Number: 3003152976-2018-00376
• Device Sequence Number: 2469194
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 515004
• Device Lot Number: 1805106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other